Drug Facts

Drug Facts
SPL v12
SPL
SPL Set ID 02c51b56-e39a-4b3b-88c6-b7dc9c165f7e
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
Inactive Ingredients
Water Glycerin Dimethicone Polytetrafluoroethylene Octyldodecanol Alcohol Isopropyl Isostearate Arachidyl Alcohol .alpha.-tocopherol Acetate, D- Sodium Chloride Hyaluronate Sodium Phenoxyethanol Acetyl Trifluoromethylphenyl Valylglycine, Dl- Adenosine Peg-100 Stearate Docosanol Polysorbate 80 Cellaburate (mw 12000, 32% Butyryl, 18% Acetyl) Polyvinyl Alcohol (100000 Mw) Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Dimethiconol (100000 Cst) Limonene, (+)- Manganese Gluconate Ion Linalool, (+/-)- Benzyl Alcohol Isohexadecane Capryloyl Salicylic Acid Isomethyl-.alpha.-ionone Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Geraniol Disodium Stearoyl Glutamate Edetate Disodium Cetyl Alcohol Cetostearyl Alcohol Methylparaben Cetearyl Glucoside Butylphenyl Methylpropional .beta.-citronellol, (r)- Butylene Glycol Coumarin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-08-01 Until 2020-12-01

Description

Avobenzone 3% Octisalate 5% Octocrylene 3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Octisalate 5% Octocrylene 3%

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 3%

Inactive Ingredients

water, glycerin, dimethicone, PTFE, octyldodecanol, alcohol denat., isopropyl isostearate, methylsilanol/silicate crosspolymer, arachidyl alcohol, tocopheryl acetate, medicago sativa (alfalfa) extract, hydrolyzed rice protein, sodium chloride, sodium hyaluronate, phenoxyethanol, acetyl trifluoromethylphenyl valylglycine, adenosine, PEG-100 stearate, behenyl alcohol, polysorbate 80, silica, cellulose acetate butyrate, polyphosphorylcholine glycol acrylate, polyvinyl alcohol, dimethicone/vinyl dimethicone crosspolymer, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer, dimethiconol, limonene, ammonium polyacryloyldimethyl taurate, manganese gluconate, linalool, benzyl alcohol, isohexadecane, capryloyl salicylic acid, alpha-isomethyl ionone, acrylamide/sodium acryloyldimethyltaurate copolymer, carbomer, geraniol, disodium stearoyl glutamate, disodium EDTA, cetyl alcohol, cetearyl alcohol, methylparaen, cetearyl glucoside, butylphenyl methylpropional, methylisothiazolinone, citronellol, butylene glycol, coumarin, fragrance

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 3%

Inactive Ingredients (Inactive ingredients)

water, glycerin, dimethicone, PTFE, octyldodecanol, alcohol denat., isopropyl isostearate, methylsilanol/silicate crosspolymer, arachidyl alcohol, tocopheryl acetate, medicago sativa (alfalfa) extract, hydrolyzed rice protein, sodium chloride, sodium hyaluronate, phenoxyethanol, acetyl trifluoromethylphenyl valylglycine, adenosine, PEG-100 stearate, behenyl alcohol, polysorbate 80, silica, cellulose acetate butyrate, polyphosphorylcholine glycol acrylate, polyvinyl alcohol, dimethicone/vinyl dimethicone crosspolymer, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer, dimethiconol, limonene, ammonium polyacryloyldimethyl taurate, manganese gluconate, linalool, benzyl alcohol, isohexadecane, capryloyl salicylic acid, alpha-isomethyl ionone, acrylamide/sodium acryloyldimethyltaurate copolymer, carbomer, geraniol, disodium stearoyl glutamate, disodium EDTA, cetyl alcohol, cetearyl alcohol, methylparaen, cetearyl glucoside, butylphenyl methylpropional, methylisothiazolinone, citronellol, butylene glycol, coumarin, fragrance

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.


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Raw Label Data

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