Brand Names:

• A-Fil
• Ammens Medicated
• Balmex
• Boudreaux's Butt Paste
• Critic-Aid Skin Care Pack
• Deeptan
• Deeptan Suntan Oil Supreme
• Delazinc
• Desitin
• Hydroquinone Skin Bleaching with Sunscreens
• Neutrogena Glow Sunless Tanning
• Neutrogena Sensitive Skin Sunblock
• Dr. Scholl's Medicated Foot Powder
• Silon
• Sun Shades Sport Sunscreen SPF 45+
• Ultraquin
• Ultrastop Spf 15
• Zincofax Extra Strength
• Zincofax Fragrance-Free
• Zincofax Original
• Zinc Oxide

Dosage Forms:

• Stick
• Lotion
• Spray
• Cream
• Liquid
• Ointment
• Gel/Jelly

Uses of This Medicine:

Sunscreen agents are used to prevent sunburn. Limiting your exposure to the sun and using sunscreen agents when in the sun may help prevent early wrinkling of the skin and skin cancer. There are two kinds of sunscreen agents: chemical and physical. Chemical sunscreen agents protect you from the sun by absorbing the ultraviolet (UV) and visible sun rays, while physical sunscreen agents reflect, scatter, absorb, or block these rays.

Sunscreen agents often contain more than one ingredient. For example, products may contain one ingredient that provides protection against the ultraviolet A (UVA) sun rays and another ingredient that protects you from the ultraviolet B (UVB) sun rays, which are more likely to cause sunburn than the UVA sun rays. Ideally, coverage should include protection against both UVA and UVB sun rays.

The sun protection factor (SPF) that you find on the label of these products tells you the minimum amount of UVB sunlight that is needed with that product to produce redness on sunscreen-protected skin as compared with unprotected skin. Sunscreen products with high SPFs will provide more protection against the sun.

Sunscreen products are available with and without your doctor's prescription. If you are using this medicine without a prescription, carefully read and follow any precautions on the label.

Before Using This Medicine:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Infants under 6 months of age should be kept out of the sun. Sunscreen agents should not be used on infants under 6 months of age because of increased chance of side effects. Children 6 months of age and older should be kept out of the sun or have limited exposure to the sun. Sunscreen agents with a sun protection factor (SPF) of at least 15 should be applied during exposure to the sun. Lotion sunscreen products are preferred for use in children. Alcohol-based sunscreen products should be avoided because they can cause irritation.

Older adults—

It is believed that the elderly, who spend little time in the sun and use sunscreen agents frequently, may be at risk for vitamin D deficiency (which may result in bone disease and fracture), although this has not been proven. To help you get enough vitamin D, it is recommended that you eat food rich in vitamin D, such as fortified milk or fatty fish. Your doctor may also advise you to take vitamin D supplements. Check with your doctor about this.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Skin conditions or diseases, especially those caused or worsened by exposure to light—Worsening of skin condition may occur.

Proper Use of This Medicine:

Sunscreen agents are for external use only. These products usually come with patient directions. Read them carefully before using any product.

In choosing the sunscreen product, you may consider the following:

• Type of Activity—Take precautions when you are in places of higher elevations (mountains) or on reflective surfaces (concrete, sand, snow, or water), as these may increase the likelihood of sun damage to the skin. Use a sunscreen with ultraviolet A/ultraviolet B (UVA/UVB) coverage and with a sun protection factor (SPF) of 15 or higher. Activities that make you sweat, such as outdoor jobs (gardeners, construction workers), outdoor sports (tennis) or exercise, prolonged sunbathing, or water sports such as swimming, water-skiing, or wind surfing, may result in the removal of the sunscreen agent from the skin. Use a water-resistant or waterproof sunscreen agent with SPF of 15 or more. When possible, also wear a hat, long-sleeved shirt, long pants, and UV-opaque sunglasses. Wearing UV-opaque sunglasses when you are in the sun is also necessary because the sun rays can cause cataracts.
• Age—Do not use sunscreen agents on infants younger than 6 months of age. For children 6 months of age and older, use a lotion form of sunscreen with broad spectrum and SPF of 15 or higher. Avoid using alcohol-based sunscreen products for this age group.
• Site of application—For the ear and nose, use a physical sunscreen agent. For the lips, use a gel-based lip sunscreen or lip balm.
• Skin condition—If your skin is dry, use a cream or lotion form of sunscreen agent. If your skin is oily, use an alcohol or gel-based sunscreen. Avoid using alcohol-based sunscreens on eczematous or inflamed skin.

The following are skin types (complexions) and the appropriate sunscreen agent that should be used:

• Very fair; always burns easily; rarely tans—Use SPF 20 to 30.
• Fair; always burns easily; tans minimally—Use SPF 12 to 20.
• Light; burns moderately; tans gradually (light brown)—Use SPF 8 to 12.
• Medium; burns minimally; always tans well (moderate brown)—Use SPF 4 to 8.
• Dark; rarely burns; tans profusely (dark brown)—Use SPF 2 to 4.

Before every exposure to the sun, apply an appropriate sunscreen product that protects you against ultraviolet (UV) sun rays. For maximum sun protection, sunscreens should be applied uniformly and thickly to all exposed skin surfaces (including the lips, using lip sunscreen or lip balm). Sunscreen products containing aminobenzoic acid, lisadimate, padimate O, or roxadimate should be applied 1 to 2 hours before sun exposure. Other sunscreen products should be applied 30 minutes before sun exposure, unless otherwise directed by the package instructions. Lip sunscreens should be applied 45 to 60 minutes before sun exposure.

Because most sunscreens are easily removed from the skin, you should reapply these products liberally every 1 to 2 hours for adequate protection. You should reapply sunscreen especially after swimming or heavy perspiration. Lip sunscreens should be reapplied liberally at least once every hour while you are in the sun and also before and after swimming, after eating and drinking, and during other activities that remove it from the lips.

Keep sunscreen products (e.g., sprays) away from the eyes.

Some sunscreen agents contain alcohol and are flammable. Do not use near heat, near open flame, or while smoking.

Follow your doctor's orders or the directions on the label. The following information includes only the average dose of sunscreen agents.

• For topical dosage forms (cream, gel, lotion, lip balm, oil, spray, and stick):
  • For sunburn (prevention):
    • Adults, teenagers, and children 6 months of age and older—Apply liberally and evenly to exposed area(s) of skin (including the lips, using lip sunscreen or lip balm) before sun exposure. Reapply when needed.
    • Infants younger than 6 months of age—Use is not recommended.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

If rash or irritation develops, stop using the sunscreen and check with your doctor.

Sunscreen agents containing aminobenzoic acid, lisadimate, padimate O, or roxadimate may discolor and stain light-colored fabrics yellow.

In addition to using sunscreen agents, it is advisable to minimize exposure to the sun from 10 a.m. to 2 p.m. (11 a.m. to 3 p.m. daylight savings time) when the sun is at its strongest. Take extra precautions also on cloudy or overcast days and around reflective surfaces such as concrete, sand, snow, or water, since these surfaces can reflect the sun's damaging rays. Wear protective clothing including a hat, long-sleeved shirt, and long pants. Sunglasses also should be worn to avoid sun damage to the eyes (cataract formation). Avoid sunlamps and tanning parlors because these can damage the skin and eyes as direct sunlight can.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Acne

burning, itching, or stinging of the skin

early appearance of redness or swelling of the skin

late appearance of rash with or without weeping blisters that become crusted, especially in sun-exposed areas, and may extend to unexposed areas of the skin

pain in hairy areas

pus in the hair follicles

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Drying or tightening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.