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

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Drug Facts

Active ingredient

Avobenzone 3%

Homosalate 10%

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, C12-15 alkyl benzoate, propylene glycol, diisopropyl sebacate, styrene/acrylates copolymer, glycerin, alcohol denat., dimethicone, potassium cetyl phosphate, acrylates copolymer, ammonium polyacryloyldimethyl taurate, caprylic/capric triglyceride, caprylyl glycol, diethylhexyl syringylidenemalonate, disodium EDTA, glyceryl stearate, hydroxypropyl methylcellulose, isopropyl lauroyl sarcosinate, myristic acid, palmitic acid, PEG-100 stearate, PEG-8 laurate, pentylene glycol, phenoxyethanol, sodium chloride, stearic acid, t-butyl alcohol, tocopherol, triethanolamine

Questions or comments?

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

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

image of a label

image of a label
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS DERMO KIDS GENTLE FACE AND BODY BROAD SPECTRUM SPF 60 SUNSCREEN WATER RESISTANT 80 MINUTES 
avobenzone, homosalate, octisalate and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-374
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) HOMOSALATE100 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)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
ISOPROPYL LAUROYL SARCOSINATE (UNII: LYR06W430J)  
MYRISTIC ACID (UNII: 0I3V7S25AW)  
PALMITIC ACID (UNII: 2V16EO95H1)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-374-01200 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2016
2NDC:49967-374-02300 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2016
3NDC:49967-374-033 mL in 1 PACKET; Type 0: Not a Combination Product11/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/01/2016
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.185931458manufacture(49967-374) , pack(49967-374)

Revised: 12/2023
Document Id: 489ddddd-5b3e-47af-ad63-224c94a23fc4
Set id: f296e5ef-728a-4d57-8d65-7d88b1f90f88
Version: 9
Effective Time: 20231231
 
L'Oreal USA Products Inc