drug facts

drug facts
SPL v1
SPL
SPL Set ID 6dbbc8ce-9457-4405-bb38-aa0c7550c62c
Route
topical
Published
Effective Date 2024-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (100 mg) octisalate (50 mg) octocrylene (70 mg)
Inactive Ingredients
water c15-19 alkane niacinamide glycerin butylene glycol silicon dioxide titanium dioxide hydroxyacetophenone pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) potassium hydroxide sodium thiosulfate taraxacum officinale root trisodium ethylenediamine disuccinate shea butter ammonium acryloyldimethyltaurate/vp copolymer arachidyl alcohol arachidyl glucoside docosanol caprylyl glycol carbomer homopolymer, unspecified type citric acid monohydrate mica pentylene glycol behenyl acrylate polymer polyglyceryl-4 caprate sodium dilauramidoglutamide lysine stannic oxide xanthan gum fd&c red no. 4 phenoxyethanol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-15

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 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

For sunscreen use:

● 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, C15-19 alkane, niacinamide, glycerin, butylene glycol, silica, titanium dioxide, hydroxyacetophenone, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, potassium hydroxide, sodium thiosulfate, taraxacum officinale (dandelion) rhizome/root extract, trisodium ethylenediamine disuccinate, 2-mercaptonicotinoyl glycine, butyrospermum parkii (shea) butter, ammonium acryloyldimethyltaurate/VP copolymer, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, caprylyl glycol, carbomer, citric acid, mica, pentylene glycol, poly c10-30 alkyl acrylate, polyglyceryl-4 caprate, sodium dilauramidoglutamide lysine, tin oxide, xanthan gum, red 4, phenoxyethanol

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 7%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Questions Or Comments?

Call toll free 1-800-946-4453

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

For sunscreen use:

● 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, C15-19 alkane, niacinamide, glycerin, butylene glycol, silica, titanium dioxide, hydroxyacetophenone, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, potassium hydroxide, sodium thiosulfate, taraxacum officinale (dandelion) rhizome/root extract, trisodium ethylenediamine disuccinate, 2-mercaptonicotinoyl glycine, butyrospermum parkii (shea) butter, ammonium acryloyldimethyltaurate/VP copolymer, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, caprylyl glycol, carbomer, citric acid, mica, pentylene glycol, poly c10-30 alkyl acrylate, polyglyceryl-4 caprate, sodium dilauramidoglutamide lysine, tin oxide, xanthan gum, red 4, phenoxyethanol

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-946-4453

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

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