1177, 1178 Sunscreen

1177, 1178 Sunscreen
SPL v4
SPL
SPL Set ID c3142ddb-74ea-a7d1-e053-2a95a90a26f3
Route
TOPICAL
Published
Effective Date 2021-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Oxybenzone (5 g) Homosalate (6 g) Octisalate
Inactive Ingredients
Carbomer Interpolymer Type A (55000 Cps) Edetate Disodium Dimethicone 350 Sorbitol Solution 70% Trolamine Butylated Hydroxyanisole Eicosyl Povidone Sorbitan Monostearate Cetyl Alcohol Water Butylated Hydroxytoluene Propylparaben Stearic Acid Polyoxyl 20 Cetostearyl Ether Glyceryl Stearate Se Methylparaben

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-27
Description

Homosalate 6%, Octinoxate 7.5%, Octisalate 5%, Oxygenzone 5%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Homosalate 6%, Octinoxate 7.5%, Octisalate 5%, Oxygenzone 5%

Uses

. Protects from excessive heat and direct sun

. Helps prevent sunburns

. Higher SPF gives more sunburn protection

. For skin highly sensitive to sunburn

Label

1177 Sunscreen

Warnings

For External Use Only.

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin carcer or early skin aging.

Directions

. Apply liberally 15 minutes before sun exposure

. Reapply at least every 2 hours

. Children under 6 months: as a doctor

Do Not Use

On damaged or broken skin

Questions?

1-888-DYNAREX Monday - Friday, 9AM - 5PM EST

Active Ingredients

Homosalate 6%, Octinoxate 7.5%, Octisalate 5%, Oxygenzone 5%

Inactive Ingredients

Antaron V-220, Butylated Hydroxyanisole, Butylated Hydroxytoluene, Carbopol Ultrez 10, Ceteareth 20, Cetyl Alcohol, Dimethicone 350, Edetate Disodium, Glyceryl Stearate SE, Methylparaben, Propylparaben, Purified Water, Sorbitan Monostearate, Sorbitol Solution, Stearic Acid, Trolamine

When Using This Product

. Keep out of eyes

. Rinse with water to remove

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center 800-222-1222) right away.

Structured Label Content

Uses

. Protects from excessive heat and direct sun

. Helps prevent sunburns

. Higher SPF gives more sunburn protection

. For skin highly sensitive to sunburn

Label

1177 Sunscreen

Purpose

Sunscreen

Warnings

For External Use Only.

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin carcer or early skin aging.

Directions

. Apply liberally 15 minutes before sun exposure

. Reapply at least every 2 hours

. Children under 6 months: as a doctor

Do Not Use (Do not use)

On damaged or broken skin

Questions?

1-888-DYNAREX Monday - Friday, 9AM - 5PM EST

Active Ingredients

Homosalate 6%, Octinoxate 7.5%, Octisalate 5%, Oxygenzone 5%

Inactive Ingredients (Inactive ingredients)

Antaron V-220, Butylated Hydroxyanisole, Butylated Hydroxytoluene, Carbopol Ultrez 10, Ceteareth 20, Cetyl Alcohol, Dimethicone 350, Edetate Disodium, Glyceryl Stearate SE, Methylparaben, Propylparaben, Purified Water, Sorbitan Monostearate, Sorbitol Solution, Stearic Acid, Trolamine

When Using This Product (When using this product)

. Keep out of eyes

. Rinse with water to remove

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center 800-222-1222) right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:30.062727 · Updated: 2026-03-14T23:05:17.700396