Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 451e50a2-2dd7-4c90-88c9-b9f9056d7ee3
Route
TOPICAL
Published
Effective Date 2024-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (150 mg) Octisalate (50 mg) Octocrylene (70 mg)
Inactive Ingredients
Water Alcohol Styrene/acrylamide Copolymer (500000 Mw) Dimethicone 2-ethylhexyl Acrylate, Methacrylate, Methyl Methacrylate, Or Butyl Methacrylate/hydroxypropyl Dimethicone Copolymer (30000-300000 Mw) Tocopherol Dicaprylyl Ether Sodium Polyacrylate (2500000 Mw) Sodium Dodecylbenzenesulfonate Sodium Benzoate Diethylhexyl Syringylidenemalonate Phenoxyethanol Peg-8 Laurate Trisodium Ethylenediamine Disuccinate Menthyl Lactate, (-)- Pentylene Glycol Mentha X Piperita Whole Xanthan Gum Propanediol Leontopodium Nivale Subsp. Alpinum Flowering Top Caprylyl Glycol Medium-chain Triglycerides Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Moringa Oleifera Leaf Sodium Phosphate, Dibasic, Anhydrous Butylene Glycol Citric Acid Monohydrate Potassium Sorbate Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-22 Until 2027-03-11

Description

Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 15% 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%

Homosalate 15%

Octisalate 5%

Octocrylene 7%

Flammable Until Dry.

Do not use near fire, flame, or heat.

Inactive Ingredients

water, alcohol denat., styrene/acrylates copolymer, dimethicone, acrylates/dimethicone copolymer, tocopherol, dicaprylyl ether, sodium polyacrylate, sodium dodecylbenzenesulfonate, sodium benzoate, diethylhexyl syringylidenemalonate, phenoxyethanol, PEG-8 laurate, trisodium ethylenediamine disuccinate, menthyl lactate, pentylene glycol, mentha piperita (peppermint) extract, xanthan gum, propanediol, leontopodium alpinum flower/leaf extract, caprylyl glycol, caprylic/capric triglyceride, acrylates/c10-30 alkyl acrylate crosspolymer, moringa oleifera seed extract, rosa meichibon/delgramaue callus, disodium phosphate, butylene glycol, citric acid, potassium sorbate, glycerin, 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%

Homosalate 15%

Octisalate 5%

Octocrylene 7%

Flammable Until Dry. (Flammable until dry.)

Do not use near fire, flame, or heat.

Inactive Ingredients (Inactive ingredients)

water, alcohol denat., styrene/acrylates copolymer, dimethicone, acrylates/dimethicone copolymer, tocopherol, dicaprylyl ether, sodium polyacrylate, sodium dodecylbenzenesulfonate, sodium benzoate, diethylhexyl syringylidenemalonate, phenoxyethanol, PEG-8 laurate, trisodium ethylenediamine disuccinate, menthyl lactate, pentylene glycol, mentha piperita (peppermint) extract, xanthan gum, propanediol, leontopodium alpinum flower/leaf extract, caprylyl glycol, caprylic/capric triglyceride, acrylates/c10-30 alkyl acrylate crosspolymer, moringa oleifera seed extract, rosa meichibon/delgramaue callus, disodium phosphate, butylene glycol, citric acid, potassium sorbate, glycerin, 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.


Advanced Ingredient Data


Raw Label Data

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