Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 60689efb-2dd4-4322-a621-54eb2c3c3dc2
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 Silicon Dioxide Dimethicone Isononyl Isononanoate Propanediol Bis-peg-18 Methyl Ether Dimethyl Silane Polyglyceryl-6 Distearate Hydrolyzed Jojoba Esters (acid Form) Tocopherol Meadowfoam Seed Oil Cyclodextrins Pea Adenosine Capryloyl Salicylic Acid Citric Acid Monohydrate Edetate Disodium Hydroxyacetophenone Scutellaria Baicalensis Root Hyaluronate Sodium Sodium Hydroxide Titanium Dioxide Acacia Decurrens Flower Wax Caprylyl Glycol Cetyl Alcohol Disodium Stearoyl Glutamate Helianthus Annuus Seed Wax Polyglycerin-3 Xanthan Gum Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Dimethiconol (70 Cst) Benzyl Alcohol Geraniol Limonene, (+)- D&c Red No. 33 Phenoxyethanol Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-06-01 Until 2027-03-18

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, silica, dimethicone, isononyl isononanoate, propanediol, bis-PEG-18 methyl ether dimethyl silane, polyglyceryl-6 distearate, jojoba esters, tocopherol, limnanthes alba (meadowfoam) seed oil, cyclodextrin, hydrolyzed lupine protein, pisum sativum (pea) extract, adenosine, capryloyl salicylic acid, citric acid, disodium EDTA, hydrolyzed linseed extract, hydroxyacetophenone, scutellaria baicalensis root extract, sodium hyaluronate, sodium hydroxide, titanium dioxide, acacia decurrens flower wax, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer, caprylyl glycol, cetyl alcohol, disodium stearoyl glutamate, helianthus annuus (sunflower) seed wax, polyglycerin-3, polyglyceryl-3 beeswax, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, dimethiconol, benzyl alcohol, geraniol, limonene, red 33, phenoxyethanol, sodium benzoate, 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%

Inactive Ingredients (Inactive ingredients)

water, glycerin, silica, dimethicone, isononyl isononanoate, propanediol, bis-PEG-18 methyl ether dimethyl silane, polyglyceryl-6 distearate, jojoba esters, tocopherol, limnanthes alba (meadowfoam) seed oil, cyclodextrin, hydrolyzed lupine protein, pisum sativum (pea) extract, adenosine, capryloyl salicylic acid, citric acid, disodium EDTA, hydrolyzed linseed extract, hydroxyacetophenone, scutellaria baicalensis root extract, sodium hyaluronate, sodium hydroxide, titanium dioxide, acacia decurrens flower wax, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer, caprylyl glycol, cetyl alcohol, disodium stearoyl glutamate, helianthus annuus (sunflower) seed wax, polyglycerin-3, polyglyceryl-3 beeswax, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, dimethiconol, benzyl alcohol, geraniol, limonene, red 33, phenoxyethanol, sodium benzoate, 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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