Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID d8449209-65d0-43c6-8750-0f460a950157
Route
TOPICAL
Published
Effective Date 2024-06-26
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 Isononyl Isononanoate Propanediol Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Alcohol Bis-peg-18 Methyl Ether Dimethyl Silane Polyglyceryl-6 Distearate Hydrolyzed Jojoba Esters (acid Form) Tocopherol Meadowfoam Seed Oil Acacia Decurrens Flower Wax Guanosine Cyathea Medullaris Leaf Hyaluronate Sodium Sodium Hydroxide Sodium Dodecylbenzenesulfonate Sodium Benzoate D&c Red No. 33 Sodium Levulinate Phenoxyethanol Adenosine Peg-8 Laurate Polyglycerin-3 Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Dimethiconol (100000 Cst) Limonene, (+)- Xanthan Gum Benzyl Alcohol Cinnamic Acid Leontopodium Nivale Subsp. Alpinum Flowering Top Capryloyl Salicylic Acid Caprylyl Glycol Geraniol Disodium Stearoyl Glutamate Edetate Disodium Cetyl Alcohol Citric Acid Monohydrate Potassium Sorbate Scutellaria Baicalensis Root Levulinic Acid Styrene/acrylamide Copolymer (500000 Mw) Glyceryl Caprylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-28 Until 2025-12-07

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%

Flammable Until Dry.

Do not use near fire, flame or heat.

Inactive Ingredients

water, glycerin, dimethicone, isononyl isononanoate, propanediol, vinyl dimethicone/methicone silsesquioxane crosspolymer, alcohol denat., bis-PEG-18 methyl ether dimethyl silane, polyglyceryl-6 distearate, jojoba esters, tocopherol, limnanthes alba (meadowfoam) seed oil, acacia decurrens flower wax, guanosine, cyathea medullaris leaf extract, sodium hyaluronate, hydrolyzed linseed extract, sodium hydroxide, sodium dodecylbenzenesulfonate, sodium benzoate, RED 33, sodium levulinae, phenoxyethanol, adenosine, PEG-8 laurate, helianthus annuus (sunflower) seed wax, polyglyceryl-3 beeswax, polyglycerin-3, ammonium acryloyldimethyltaurae/steareth-25 methacrylate crosspolymer, dimethicone/vinyl dimethicone crosspolyer, dimethiconol, limonene, xanthan gum, benzyl alcohol, cinnamic acid, leontopodium alpinum flower/leaf extract, capryloyl salicylic acid, caprylyl glycol, geraniol, disodium stearoyl glutamate, disodium EDTA, cetyl alcohol, citric acid, potassium sorbate, sculellaria baicalensis root extract, levulinic acid, styrene/acrylaes copolymer, clyberyl caprylate, 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 7%

Flammable Until Dry. (Flammable until dry.)

Do not use near fire, flame or heat.

Inactive Ingredients (Inactive ingredients)

water, glycerin, dimethicone, isononyl isononanoate, propanediol, vinyl dimethicone/methicone silsesquioxane crosspolymer, alcohol denat., bis-PEG-18 methyl ether dimethyl silane, polyglyceryl-6 distearate, jojoba esters, tocopherol, limnanthes alba (meadowfoam) seed oil, acacia decurrens flower wax, guanosine, cyathea medullaris leaf extract, sodium hyaluronate, hydrolyzed linseed extract, sodium hydroxide, sodium dodecylbenzenesulfonate, sodium benzoate, RED 33, sodium levulinae, phenoxyethanol, adenosine, PEG-8 laurate, helianthus annuus (sunflower) seed wax, polyglyceryl-3 beeswax, polyglycerin-3, ammonium acryloyldimethyltaurae/steareth-25 methacrylate crosspolymer, dimethicone/vinyl dimethicone crosspolyer, dimethiconol, limonene, xanthan gum, benzyl alcohol, cinnamic acid, leontopodium alpinum flower/leaf extract, capryloyl salicylic acid, caprylyl glycol, geraniol, disodium stearoyl glutamate, disodium EDTA, cetyl alcohol, citric acid, potassium sorbate, sculellaria baicalensis root extract, levulinic acid, styrene/acrylaes copolymer, clyberyl caprylate, 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

All Sections (JSON)