drug facts

drug facts
SPL v1
SPL
SPL Set ID c21fdc5e-236a-4a8e-ad59-1d9cd7507424
Route
topical
Published
Effective Date 2024-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (100 mg) octisalate (50 mg) octocrylene (27 mg)
Inactive Ingredients
water alkyl (c12-15) benzoate glyceryl stearate se glycerin pentylene glycol hydroxyacetophenone chlorphenesin trisodium ethylenediamine disuccinate citric acid monohydrate tert-butyl alcohol phenoxyethanol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-14

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 2.7%


Medication Information

Warnings

For external use only

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
Purpose

Sunscreen

Directions

For sunscreen use:

  • shake well 
  • 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
Other Information
  • protect the product in this container from excessive heat and direct sun
Inactive Ingredients

water, c12-15 alkyl benzoate, glyceryl stearate SE, glycerin, pentylene glycol, sodium acryloyldimethyltaurate/VP crosspolymer, hydroxyacetophenone, chlorphenesin, trisodium ethylenediamine disuccinate, citric acid, t-butyl alcohol, phenoxyethanol, soluble collagen

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 2.7%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.7%

Questions Or Comments?

L'OREAL USA, Inc., 10 Hudson Yards,

New York, NY 10001

1-800-322-2046

Made in USA of US and/or Imported Ingredients

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

Warnings

For external use only

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
Purpose

Sunscreen

Directions

For sunscreen use:

  • shake well 
  • 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
Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

water, c12-15 alkyl benzoate, glyceryl stearate SE, glycerin, pentylene glycol, sodium acryloyldimethyltaurate/VP crosspolymer, hydroxyacetophenone, chlorphenesin, trisodium ethylenediamine disuccinate, citric acid, t-butyl alcohol, phenoxyethanol, soluble collagen

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.7%

Questions Or Comments? (Questions or comments?)

L'OREAL USA, Inc., 10 Hudson Yards,

New York, NY 10001

1-800-322-2046

Made in USA of US and/or Imported Ingredients

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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