Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 636e38d8-f83b-4000-9174-1015a56f6292
Route
TOPICAL
Published
Effective Date 2024-06-28
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
EXPORT ONLY Active Since 2024-04-25

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 5% 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 sunscren 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 5%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients

water, glycerin, alcohol denat., propanediol, dimethicone, butyloctyl salicylate, isopropyl isostearate, behenyl alcohol, octyldodecanol, boron nitride, phenoxyethanol, cetyl alcohol, polyacrylamide, disodium stearoyl glutamate, hydrolyzed soy protein, silica, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer, dimethicone/vinyl dimethicone crosspolymer, c13-14 isoalkane, glycine soja (soybean) protein, fragrance, PEG-100 stearate, cetearyl alcohol, panthenol, tocopheryl acetate, retinyl palmitate, laureth-7, capryloyl salicylic acid, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, trisodium ethylenediamine disuccinate, caprylyl glycol, cetearyl glucoside, citric acid, carbomer, 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

Questions Or Comments?

L'Oreal USA S/D, Inc., Dist., 10 Hudson Yards,

New York, NY 10001  1-800-322-2036

When Using This Product

keep out of eyes. Rinse with water to remove.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If 

rash occurs


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 sunscren 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 5%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients (Inactive ingredients)

water, glycerin, alcohol denat., propanediol, dimethicone, butyloctyl salicylate, isopropyl isostearate, behenyl alcohol, octyldodecanol, boron nitride, phenoxyethanol, cetyl alcohol, polyacrylamide, disodium stearoyl glutamate, hydrolyzed soy protein, silica, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer, dimethicone/vinyl dimethicone crosspolymer, c13-14 isoalkane, glycine soja (soybean) protein, fragrance, PEG-100 stearate, cetearyl alcohol, panthenol, tocopheryl acetate, retinyl palmitate, laureth-7, capryloyl salicylic acid, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, trisodium ethylenediamine disuccinate, caprylyl glycol, cetearyl glucoside, citric acid, carbomer, 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

Questions Or Comments? (Questions or comments?)

L'Oreal USA S/D, Inc., Dist., 10 Hudson Yards,

New York, NY 10001  1-800-322-2036

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

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.

Stop Use and Ask A Doctor If  (Stop use and ask a doctor if )

rash occurs


Advanced Ingredient Data


Raw Label Data

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