Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 8840da10-63cb-47ea-ad46-1ae6df1639e8
Route
TOPICAL
Published
Effective Date 2023-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octisalate (50 mg) Octocrylene (70 mg)
Inactive Ingredients
Water Glycerin Dimethicone Alcohol Propanediol Polytetrafluoroethylene Isopropyl Isostearate Docosanol Octyldodecanol Phenoxyethanol Cetyl Alcohol Disodium Stearoyl Glutamate Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Hydrolyzed Soy Protein (enzymatic; 2000 Mw) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) C13-14 Isoparaffin Peg-100 Stearate Soy Protein Cetostearyl Alcohol Dimethiconol (2000 Cst) .alpha.-tocopherol Acetate Panthenol Vitamin A Palmitate Laureth-7 Capryloyl Salicylic Acid Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Edetate Disodium Carbomer Homopolymer, Unspecified Type Cetearyl Glucoside Calcium Pidolate Sodium Cocoyl Glutamate Pentylene Glycol Ethylhexylglycerin Sodium Benzoate Benzyl Salicylate Benzyl Alcohol Yeast, Unspecified Benzyl Benzoate Potassium Sorbate Linalool, (+/-)- Centella Asiatica Whole .alpha.-hexylcinnamaldehyde .beta.-citronellol, (r)- Limonene, (+)- Geraniol Isomethyl-.alpha.-ionone Salicyloyl Phytosphingosine Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-10-02 Until 2023-12-01

Description

Avobenzone 3% Octisalate 5% Octocrylene 7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Octisalate 5% Octocrylene 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

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

Do Not Use

on damaged or broken skin

Other Information

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

Active Ingredients

Avobenzone 3%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients

water, glycerin, dimethicone, alcohol denat., propanediol, PTFE, isopropyl isostearate, behenyl alcohol, octyldodecanol, phenoxyethanol, cetyl alcohol, polyacrylamide, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer, disodium stearoyl glutamate, vinyl dimethicone/methicone silsequioxane crosspolymer, hydrolyzed soy protein, dimethicone/vinyl dimethicone crosspolymer, C13-14 isoparaffin, PEG-100 stearate, glycine soja (soybean) protein, fragrance, cetearyl alcohol, dimethiconol, tocopheryl acetate, panthenol, retinyl palmitate, laureth-7, capryloyl salicylic acid, acetyl trifluoromethylphenyl valyglycine, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, disodium EDTA, carbomer, caprylyl glycol, cetearyl glucoside, calcium PCA, sodium cocoyl glutamate, pentylene glycol, ethylhexylglycerin, sodium benzoate, benzyl salicylate, benzyl alcohol, yeast extract, benzyl benzoate, potassium sorbate, linalool, centella asiatica extract, hexyl cinnamal, citronellol, limonene, geraniol, alpha-isomethyl ionone, salicyloyl phytosphingosine, tocopherol

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

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

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)

Avobenzone 3%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients (Inactive ingredients)

water, glycerin, dimethicone, alcohol denat., propanediol, PTFE, isopropyl isostearate, behenyl alcohol, octyldodecanol, phenoxyethanol, cetyl alcohol, polyacrylamide, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer, disodium stearoyl glutamate, vinyl dimethicone/methicone silsequioxane crosspolymer, hydrolyzed soy protein, dimethicone/vinyl dimethicone crosspolymer, C13-14 isoparaffin, PEG-100 stearate, glycine soja (soybean) protein, fragrance, cetearyl alcohol, dimethiconol, tocopheryl acetate, panthenol, retinyl palmitate, laureth-7, capryloyl salicylic acid, acetyl trifluoromethylphenyl valyglycine, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, disodium EDTA, carbomer, caprylyl glycol, cetearyl glucoside, calcium PCA, sodium cocoyl glutamate, pentylene glycol, ethylhexylglycerin, sodium benzoate, benzyl salicylate, benzyl alcohol, yeast extract, benzyl benzoate, potassium sorbate, linalool, centella asiatica extract, hexyl cinnamal, citronellol, limonene, geraniol, alpha-isomethyl ionone, salicyloyl phytosphingosine, tocopherol

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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