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 label

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-994
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
NYLON-12 (UNII: 446U8J075B)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PERLITE (UNII: 0SG101ZGK9)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-994-011 in 1 CARTON01/01/2016
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49967-994-023 mL in 1 PACKET; Type 0: Not a Combination Product01/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2015
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.185931458manufacture(49967-994)

Revised: 12/2019
Document Id: b2834efe-f6ba-42f8-b00b-d8986f897301
Set id: 06f2ced8-273e-454f-92b4-2846f6674b37
Version: 2
Effective Time: 20191229
 
L'Oreal USA Products Inc