La Roche-Posay Laboratoire Pharmaceutique Anthelios 60 Melt In Sunscreen SPF 60 by L'Oreal USA Products Inc Drug Facts

Drug Details [pdf]

LA ROCHE-POSAY LABORATOIRE PHARMACEUTIQUE ANTHELIOS 60 MELT IN SUNSCREEN SPF 60- avobenzone, homosalate, octisalate, octocrylene and oxybenzone 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 ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 5%

Oxybenzone 6%

Uses

helps prevent sunburn
higher SPF gives more sunburn protection
retains SPF after 40 minutes of activity in the water or perspiring
provides protection from the UVA rays that may contribute to skin damage and premature aging of the skin

Directions

apply evenly before sun exposure
reapply as needed or after towel drying, swimming, or perspiring
children under 6 months of age: ask a doctor

Warnings

For external use only

When using this product

keep out of eye. Rinse with water to remove.

Stop use and ask a doctor if

rash or irritation develops and lasts

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Inactive ingredients

WATER
SILICA
STYRENE/ACRYLATES COPOLYMER
BUTYLOCTYL SALICYLATE
CYCLOPENTASILOXANE
GLYCERIN
POLY C10-30 ALKYL ACRYLATE
DIETHYLHEXYL SYRINGYLIDENEMALONATE
PEG-100 STEARATE
GLYCERYL STEARATE
CAPRYLYL METHICONE
TRISILOXANE
DICAPRYLYL CARBONATE
ACRYLATES/DIMETHICONE COPOLYMER
PHENOXYETHANOL
POTASSIUM CETYL PHOSPHATE
DIMETHICONE
TOCOPHERYL ACETATE
CAPRYLYL GLYCOL
METHYLPARABEN
INULIN LAURYL CARBAMATE
CHLORPHENESIN
TRIETHANOLAMINE
ETHYLPARABEN
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
XANTHAN GUM
ETHYLHEXYLGLYCERIN
DISODIUM EDTA
DIMETHICONE CROSSPOLYMER
CASSIA ALATA LEAF EXTRACT
MALTODEXTRIN

image of a label

LA ROCHE-POSAY LABORATOIRE PHARMACEUTIQUE ANTHELIOS 60 MELT IN SUNSCREEN SPF 60
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-029
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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	50 mg in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
PEG-100 STEARATE (UNII: YD01N1999R)
TRISILOXANE (UNII: 9G1ZW13R0G)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYLPARABEN (UNII: A2I8C7HI9T)
CHLORPHENESIN (UNII: I670DAL4SZ)
ETHYLPARABEN (UNII: 14255EXE39)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 49967-029-01	1 in 1 CARTON	08/01/2009	12/04/2013
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/01/2009	12/04/2013

Labeler - L'Oreal USA Products Inc (002136794)

Name	Address	ID/FEI	Business Operations
Establishment
L'Oreal USA Products Inc		185931458	manufacture(49967-029)

Revised: 1/2020

Document Id: fb27d7ea-e1bb-47ff-8a18-14654a6d87d5

Set id: e9a20163-b6a8-41fd-95b0-c2e0c70f1e2d

Version: 3

Effective Time: 20200117

L'Oreal USA Products Inc