48eff8fa-deec-a434-e063-6294a90aa861

SPL v1
SPL
SPL Set ID 48eff8fa-deec-a434-e063-6294a90aa861
Route
topical
Published
Effective Date 2026-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (3 g) avobenzone (1.5 g) octisalate (2.25 g) homosalate (4 g)
Inactive Ingredients
silicon dioxide polyglyceryl-3 methylglucose distearate polysorbate 60 polyglyceryl-10 laurate glyceryl stearate peg-100 stearate sorbitan stearate propanediol 1,2-hexanediol tromethamine edetate disodium anhydrous peg-8 laurate butyloctyl salicylate water carbomer sodium polyacryloyldimethyl taurate xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2026-01-22

Purpose

SUNSCREEN

Description

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE


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.

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

■ reapply at least every 2 hours

■ use a water-resistant sunscreen if swimming or sweating

Other Information

■ protect the product from excessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredients

Water, Propanediol, Butyloctyl Salicylate, Silica, Hydrogenated Polydecene, 1,2-Hexanediol, Polyglyceryl-3 Methylglucose Distearate, Glyceryl Stearate, PEG-100 Stearate, Styrene/Acrylates Copolymer, Sorbitan Stearate, Polysorbate 60, Polyglyceryl-10 Laurate, Carbomer, Tromethamine, PEG-8 Laurate, Sodium Polyacryloyldimethyl Taurate, Xanthan Gum, Disodium EDTA

Description

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE

Stop Use

and ask a doctor if • rash occurs

Do Not Use

• on damaged skin or broken skin

Keep Out of Reach

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

Actiove Ingredients

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE

When Using This Product

• keep out of eyes. Rinse with water to remove.

Package Label Principal Display Panel


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.

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

■ reapply at least every 2 hours

■ use a water-resistant sunscreen if swimming or sweating

Other Information (Other information)

■ protect the product from excessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredients (Inactive ingredients)

Water, Propanediol, Butyloctyl Salicylate, Silica, Hydrogenated Polydecene, 1,2-Hexanediol, Polyglyceryl-3 Methylglucose Distearate, Glyceryl Stearate, PEG-100 Stearate, Styrene/Acrylates Copolymer, Sorbitan Stearate, Polysorbate 60, Polyglyceryl-10 Laurate, Carbomer, Tromethamine, PEG-8 Laurate, Sodium Polyacryloyldimethyl Taurate, Xanthan Gum, Disodium EDTA

Stop Use (Stop use)

and ask a doctor if • rash occurs

Do Not Use (Do not use)

• on damaged skin or broken skin

Keep Out of Reach (Keep out of reach)

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

Actiove Ingredients (Actiove ingredients)

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE

When Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove.

Package Label Principal Display Panel (PACKAGE LABEL PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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