Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID df67b49c-f8b6-4c0a-9e8d-c94dee3635ff
Route
TOPICAL
Published
Effective Date 2023-12-23
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 Dimethicone Glycerin Hydrogenated Polybutene (1300 Mw) Yellow Wax Yeast, Unspecified Guanosine Cyathea Medullaris Leaf Sucrose Stearate Sodium Polyacrylate (2500000 Mw) Sodium Hydroxide Fd&c Red No. 4 Stearic Acid Phenoxyethanol Adenosine Peg-100 Stearate Palmitic Acid Silicon Dioxide Chlorphenesin Fd&c Yellow No. 5 Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Dimethiconol (100000 Cst) Limonene, (+)- Pentylene Glycol Benzyl Alcohol Linalool, (+/-)- Caprylyl Glycol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Disodium Stearoyl Glutamate Edetate Disodium Anhydrous .beta.-citronellol, (r)- Aluminum Starch Octenylsuccinate Coumarin Glyceryl Monostearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-12-27
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 of 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, dimethicone, glycerin, hydrogenated polyisobutene, beeswax, poly C10-30 alkyl acrylate, yeast extract, guanosine, cyathea medullaris leaf extract, sucrose stearate, secale cereale (rye) seed extract, sodium polyacrylate, sodium hydroxide, red 4, stearic acid, phenoxyethanol, adenosine, PEG-100 stearate, palmitic acid, silica, chlorphenesin, yellow 5, dimethicone/vinyl dimethicone crosspolymer, dimethiconol, limonene, pentylene glycol, benzyl alcohol, linalool, caprylyl glycol, acrylates/C10-30 alkyl acrylate crosspolymer, disodium stearoyl glutamate, disodium EDTA, citronellol, aluminum starch octenylsuccinate, coumarin, glyceryl stearate, 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 of 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, dimethicone, glycerin, hydrogenated polyisobutene, beeswax, poly C10-30 alkyl acrylate, yeast extract, guanosine, cyathea medullaris leaf extract, sucrose stearate, secale cereale (rye) seed extract, sodium polyacrylate, sodium hydroxide, red 4, stearic acid, phenoxyethanol, adenosine, PEG-100 stearate, palmitic acid, silica, chlorphenesin, yellow 5, dimethicone/vinyl dimethicone crosspolymer, dimethiconol, limonene, pentylene glycol, benzyl alcohol, linalool, caprylyl glycol, acrylates/C10-30 alkyl acrylate crosspolymer, disodium stearoyl glutamate, disodium EDTA, citronellol, aluminum starch octenylsuccinate, coumarin, glyceryl stearate, 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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:35.388398 · Updated: 2026-03-14T23:02:13.859151