Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 43041108-6adb-4dd3-a75f-87f5d643c794
Route
TOPICAL
Published
Effective Date 2023-12-30
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 Polytetrafluoroethylene Alcohol Isopropyl Isostearate Docosanol Synthetic Wax (1200 Mw) Octyldodecanol C13-14 Isoparaffin Yeast, Unspecified .alpha.-tocopherol Acetate Tocopherol Hydrolyzed Soy Protein (enzymatic; 2000 Mw) Sodium Cocoyl Glutamate Sodium Benzoate Phenoxyethanol Acetyl Trifluoromethylphenyl Valylglycine, Dl- Peg-100 Stearate Ethylhexylglycerin Polyacrylamide (10000 Mw) Calcium Pidolate Salicyloyl Phytosphingosine Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Dimethiconol (100000 Cst) Limonene, (+)- Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Panthenol Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Pentylene Glycol Linalool, (+/-)- Caprylyl Glycol Capryloyl Salicylic Acid Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Edetate Disodium Cetyl Alcohol Methyl Dihydrojasmonate (synthetic) Cetostearyl Alcohol Vitamin A Palmitate Cetearyl Glucoside Potassium Sorbate .beta.-citronellol, (r)- Butylated Hydroxytoluene Laureth-7

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2017-05-01 Until 2024-06-01

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 generously and evenly 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, PTFE, alcohol denat., isopropyl isostearate, behenyl alcohol, synthetic wax, octyldodecanol, C13-14 isoparaffin, yeast extract, tocopheryl acetate, tocopherol, hydrolyzed soy protein, sodium cocoyl glutamate, sodium benzoate, phenoxyethanol, acetyl trifluoromethylphenyl valylglycine, PEG-100 stearate, ethylhexylglycerin, polyacrylamide, calcium PCA, salicyloyl phytosphingosine, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer, dimethicone/vinyl dimethicone crosspolymer, dimethiconol, limonene, vinyl dimethicone/methicone silsesquioxane crosspolymer, panthenol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, pentylene glycol, linalool, caprylyl glycol, capryloyl salicylic acid, carbomer, disodium stearoyl glutamate, disodium EDTA, cetyl alcohol, methyldihydrojasmonate, cetearyl alcohol, retinyl palmitate, cetearyl glucoside, potassium sorbate, citronellol, BHT, laureth-7, glycine soja (soybean) protein

Questions Or Comments?

1-800-LANCOME (1-800-526-2663) Monday - Friday (9 a.m. - 5 p.m. EST)

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 generously and evenly 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, PTFE, alcohol denat., isopropyl isostearate, behenyl alcohol, synthetic wax, octyldodecanol, C13-14 isoparaffin, yeast extract, tocopheryl acetate, tocopherol, hydrolyzed soy protein, sodium cocoyl glutamate, sodium benzoate, phenoxyethanol, acetyl trifluoromethylphenyl valylglycine, PEG-100 stearate, ethylhexylglycerin, polyacrylamide, calcium PCA, salicyloyl phytosphingosine, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer, dimethicone/vinyl dimethicone crosspolymer, dimethiconol, limonene, vinyl dimethicone/methicone silsesquioxane crosspolymer, panthenol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, pentylene glycol, linalool, caprylyl glycol, capryloyl salicylic acid, carbomer, disodium stearoyl glutamate, disodium EDTA, cetyl alcohol, methyldihydrojasmonate, cetearyl alcohol, retinyl palmitate, cetearyl glucoside, potassium sorbate, citronellol, BHT, laureth-7, glycine soja (soybean) protein

Questions Or Comments? (Questions or comments?)

1-800-LANCOME (1-800-526-2663) Monday - Friday (9 a.m. - 5 p.m. EST)

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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