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

La Roche Posay Laboratoire Dermatologique Anthelios Dermo Kids Gentle Face and Body Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Anthelios Dermo Kids Gentle Face and Body Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Purpose

Sunscreen

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

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

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-374
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	100 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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-374-01	200 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2016
2	NDC: 49967-374-02	300 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2016
3	NDC: 49967-374-03	3 mL in 1 PACKET; Type 0: Not a Combination Product	11/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2016

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-374)