LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 FACE ULTRA LIGHT FLUID SUNSCREEN BROAD SPECTRUM SPF 60- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Ultra Light Fluid Sunscreen Broad Spectrum SPF 60 by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Ultra Light Fluid Sunscreen Broad Spectrum SPF 60 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Cosmetique Active Production, Interspray. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 10.72 %

Octisalate 3.21%

Octocrylene 6%

Oxybenzone 3.86%

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

● apply to all skin exposed to the sun [this statement is optional]

● 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, cyclopentasiloxane, alcohol denat., silica dicaprylyl ether, styrene/acrylates copolymer, diethylhexyl syringlyidenemalonate, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexasiloxane, polymethylsilsesquioxane, nylon-12, dicaprylyl carbonate, phenoxyethanol, lauryl  PEG/PPG-18/18 methicone, sodium chloride, caprylyl glycol, PEG-8 laurate, caprylic/capric triglyceride, poly C10-30 alkyl acrylate, disteardimonium hectorite, isostearyl alcohol, p-anisic acid, disodium EDTA, 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 60 FACE ULTRA LIGHT FLUID SUNSCREEN BROAD SPECTRUM SPF 60 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-129
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	107.2 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	32.1 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	38.6 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)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
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)
PEG-8 LAURATE (UNII: 762O8IWA10)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DODECENE (UNII: WYE669F3GR)
POLOXAMER 407 (UNII: TUF2IVW3M2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-129-01	1 in 1 CARTON	06/01/2013
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-129-02	1 in 1 CARTON	06/01/2013
2		3 mL in 1 TUBE; 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	06/01/2013

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetique Active Production		282658798	manufacture(49967-129) , analysis(49967-129)

Establishment
Name	Address	ID/FEI	Business Operations
Interspray		364829903	pack(49967-129)