LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 MELT IN SUNSCREEN MILK FACE AND BODY BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion 
L'Oreal USA Products Inc

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Drug Facts

Active ingredient

Avobenzone 3%

Homosalate 10.72%

Octisalate 3.21%

Octocrylene 6%

Oxybenzone 3.86%

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, styrene/acrylates copolymer, dimethicone, polymethylsilsesquioxane, butyloctyl salicylate, glycerin, alcohol denat., poly C10-30 alkyl acrylate, caprylyl methicone, trisiloxane, acrylates/dimethicone copolymer, PEG-100 stearate, glyceryl stearate, phenoxyethanol, potassium cetyl phosphate, propylene glycol, caprylyl glycol, PEG-8 laurate, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, tocopherol, inulin lauryl carbamate, disodium EDTA, p-anisic acid, xanthan gum, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin

Questions or comments?

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

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

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LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 MELT IN SUNSCREEN MILK FACE AND BODY BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-864
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) HOMOSALATE107.2 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE32.1 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE38.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
TOCOPHEROL (UNII: R0ZB2556P8)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-864-011 in 1 CARTON01/01/201409/15/2025
1150 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49967-864-021 in 1 CARTON01/01/201409/15/2025
2150 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:49967-864-031 in 1 CARTON01/01/201409/15/2025
390 mL in 1 TUBE; Type 0: Not a Combination Product
4NDC:49967-864-045 mL in 1 PACKET; Type 0: Not a Combination Product01/01/201409/15/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/201409/15/2025
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.185931458manufacture(49967-864)

Revised: 1/2024
Document Id: 8d4c3de2-c5b3-4383-991b-d37ba01af66b
Set id: 59b84681-7bad-4ad8-9cc3-d7448c9b8ba4
Version: 15
Effective Time: 20240108
 
L'Oreal USA Products Inc