LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 45 ULTRA LIGHT SUNSCREEN FLUID WATER RESISTANT 40- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

La Roche Posay Laboratoire Dermatologique Anthelios 45 Ultra Light Sunscreen Fluid Water Resistant 40 by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Anthelios 45 Ultra Light Sunscreen Fluid Water Resistant 40 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Cosmetique Active Production, BCM COSMETIQUE SAS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

Ocybenzone 6%

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 40 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, cyclopentasiloxane, alcohol denat., silica, dicaprylyl ether, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexsiloxane, polymethylsilsesquioxane, nylon-12, dicaprylyl carbonate, phenoxyethanol, lauryl PEG/PPG-18/18 methicone, sodium chloride, caprylyl glycol, methylparaben, poly c10-30 alkyl acrylate, disteardimonium hectorite, disodium EDTA, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin, dodecene, poloxamer 407

Questions or comments?

1-888-LRP-LABO  1-888-577-5226

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 45 ULTRA LIGHT SUNSCREEN FLUID WATER RESISTANT 40 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-222
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	50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ALCOHOL (UNII: 3K9958V90M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
NYLON-12 (UNII: 446U8J075B)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DODECANE (UNII: 11A386X1QH)
POLOXAMER 407 (UNII: TUF2IVW3M2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-222-01	1 in 1 CARTON	04/01/2010
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2010

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetique Active Production		282658798	manufacture(49967-222) , analysis(49967-222)

Establishment
Name	Address	ID/FEI	Business Operations
BCM COSMETIQUE SAS		275359578	pack(49967-222)