LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 BREAKOUT FREE OIL FREE FACE DRY TOUCH BROAD SPECTRUM SPF 60 SUNSCREEN WATER RESISTANT 80 MINUTES- avobenzone, homosalate, octisalate and octocrylene lotion
L'Oreal USA Products Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 7%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use

on damaged or broken skin

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.

Directions

For sunscreen use:

●  apply generously 15 minutes before sun exposure

●  reapply:

●  after 80 minutes of swimming or sweating

●  immediately after towel drying

●  at least every 2 hours

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, silica, dicaprylyl carbonate, styrene/acrylates copolymer, butyloctyl salicylate, methyl methacrylate crosspolymer, nylon-12, PEG-100 stearate, glyceryl stearate, perlite, beeswax, ammonium polyacryloyldimethyl taurate, phenoxyethanol, PEG-8 laurate, behenyl alcohol, sodium stearoyl glutamate, chlorphenesin, p-anisic acid, xanthan gum, tocopherol, disodium EDTA, arachidyl alcohol, diethylhexyl syringylidenemalonate, propylene glycol, cassia alata leaf extract, maltodextrin, stearyl alcohol, t-butyl alcohol, caprylic/capric triglyceride

Questions or comments?

1-888-LRP-LABO 1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

image of a carton

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 BREAKOUT FREE OIL FREE FACE DRY TOUCH BROAD SPECTRUM SPF 60 SUNSCREEN WATER RESISTANT 80 MINUTES
avobenzone, homosalate, octisalate and octocrylene lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-994
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 70 mg  in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49967-994-01 1 in 1 CARTON 01/01/2016
1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:49967-994-02 3 mL in 1 PACKET; Type 0: Not a Combination Product 01/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2015
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Business Operations
L'Oreal USA, Inc. 185931458 manufacture(49967-994)

Revised: 11/2016
Document Id: 943b5f7c-1d95-4cc7-aea7-e33f53dde92d
Set id: 06f2ced8-273e-454f-92b4-2846f6674b37
Version: 1
Effective Time: 20161114
L'Oreal USA Products Inc