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
Purpose

Sunscreen

Description

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

Medication Information

Warnings

For external use only

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

Purpose

Sunscreen

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

Other Information

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

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

Description

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

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Homosalate 8%

Octisalate 5%

Octocrylene 5%

Zinc oxide 7%

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

Warnings

For external use only

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

Purpose

Sunscreen

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

Other Information (Other information)

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

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

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Homosalate 8%

Octisalate 5%

Octocrylene 5%

Zinc oxide 7%

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