LA ROCHE POSAY ANTHELIOS SUNSCREEN SPF 60 ULTRA LIGHT- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

La Roche Posay Anthelios Sunscreen SPF 60 Ultra light by

Drug Labeling and Warnings

La Roche Posay Anthelios Sunscreen SPF 60 Ultra light by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 2.7%

Homosalate 9.6%

Octisalate 2.9%

Octocrylene 5.4%

Oxybenzone 3.5%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Direction

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.
• keep away from face to avoid breathing it

Stop use and ask a doctor if

rash occurs

Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F. Avoid spraying in eyes.

Keep out of reach of children.

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

Directions

For sunscreen use:   

• spray generously and spread evenly by hand 15 minutes before sun exposure
• hold container 4 to 6 inches from skin to apply
• do not spray directly into face. Spray on hands then apply to face.
• do not apply in windy conditions
• use in a well-ventilated area
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases this risk, regularly  use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
• 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, dimethicone, isopropyl lauroyl sarcosinate, glycerin, styrene/acrylates copolymer, isotridecyl isononanoate, polyurethane-35, caprylyl methicone, octyldodecanol, phenoxyethanol, propylene glycol, caprylyl glycol, sodium stearoyl glutamate, polysorbate 61, glyceryl stearate, PEG-8 laurate, dimethiconol, octyldodecyl xyloside, PEG-12 dimethicone, p-anisic acid, stearyl alcohol, disodium EDTA, tocopherol, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin

Questions or comments?

Monday - Friday (9 a.m. - 5 p.m. EST) 1-888-LRP-LAB0 1-888-577-5226

Package Labeling:

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY ANTHELIOS SUNSCREEN SPF 60 ULTRA LIGHT 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82046-692
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	27 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	96 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	29 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	54 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	35 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL LAUROYL SARCOSINATE (UNII: LYR06W430J)
GLYCERIN (UNII: PDC6A3C0OX)
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
POLYSORBATE 61 (UNII: X9E1MY2JQG)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-8 LAURATE (UNII: 762O8IWA10)
OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TOCOPHEROL (UNII: R0ZB2556P8)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
SENNA ALATA LEAF (UNII: 4BXR6YZN92)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82046-692-01	143 g in 1 CAN; Type 0: Not a Combination Product	01/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2014

Labeler - L'Oreal USA, Inc. (002136794)