Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 817c882d-72f3-4ee7-8da2-a4a32f9d167f
Route
TOPICAL
Published
Effective Date 2024-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (80 mg) Octisalate (50 mg) Octocrylene (70 mg) Zinc Cation
Inactive Ingredients
Water Glycerin Coco-caprylate/caprate Propanediol Butyloctyl Salicylate Steareth-20 Ethylhexyl Methoxycrylene Rice Bran Butylene Glycol Steareth-2 Levomenol Hydroxyacetophenone Polyhydroxystearic Acid (2300 Mw) Diethylhexyl Syringylidenemalonate Chlorphenesin Caprylyl Glycol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Citric Acid Monohydrate Xanthan Gum Triethoxycaprylylsilane Trisodium Ethylenediamine Disuccinate Medium-chain Triglycerides Sorbitan Isostearate Polysorbate 60 Palmitoyl Tripeptide-8 Dextran 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-01
Description

Homosalate 8% Octisalate 5% Octocrylene 5% Zinc oxide 7%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Homosalate 8% Octisalate 5% Octocrylene 5% Zinc oxide 7%

Uses

- helps prevent sunburn

- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Section 51945-4

Warnings

For external use only

Directions

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk,

    regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

   ● limit time in the sun, especially from 10 a.m. – 2 p.m.

   ● wear long-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

Do Not Use

on damaged or broken skin

Other Information

protect the product in this container from excessive heat and direct sun

Active Ingredients

Homosalate 8%

Octisalate 5%

Octocrylene 5%

Zinc oxide 7%

Inactive Ingredients

water, glycerin, coco-caprylate/caprate, propanediol, butyloctyl salicylate, steareth-20, c12-22 alkyl acrylate/hydroxyethylacrylate copolymer, ethylhexyl methoxycrylene, oryza sativa (rice) bran wax, butylene glycol, steareth-2, bisabolol, hydroxyacetophenone, polyhydroxystearic acid, diethylhexyl syringylidenemalonate, chlorphenesin, caprylyl glycol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, citric acid, xanthan gum, triethoxycaprylylsilane, trisodium ethylenediamine disuccinate, caprylic/capric triglyceride, sorbitan isostearate, polysorbate 60, palmitoyl tripeptide-8, dextran

Questions Or Comments?

Call 1-800-811-1660

Monday - Friday (9 a.m. - 5 p.m. CST)

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

rash occurs

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses

- helps prevent sunburn

- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk,

    regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

   ● limit time in the sun, especially from 10 a.m. – 2 p.m.

   ● wear long-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)

protect the product in this container from excessive heat and direct sun

Active Ingredients (Active ingredients)

Homosalate 8%

Octisalate 5%

Octocrylene 5%

Zinc oxide 7%

Inactive Ingredients (Inactive ingredients)

water, glycerin, coco-caprylate/caprate, propanediol, butyloctyl salicylate, steareth-20, c12-22 alkyl acrylate/hydroxyethylacrylate copolymer, ethylhexyl methoxycrylene, oryza sativa (rice) bran wax, butylene glycol, steareth-2, bisabolol, hydroxyacetophenone, polyhydroxystearic acid, diethylhexyl syringylidenemalonate, chlorphenesin, caprylyl glycol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, citric acid, xanthan gum, triethoxycaprylylsilane, trisodium ethylenediamine disuccinate, caprylic/capric triglyceride, sorbitan isostearate, polysorbate 60, palmitoyl tripeptide-8, dextran

Questions Or Comments? (Questions or comments?)

Call 1-800-811-1660

Monday - Friday (9 a.m. - 5 p.m. CST)

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs

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

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:17.285824 · Updated: 2026-03-14T23:03:17.077951