LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS AOX DAILY ANTIOXIDANT SERUM BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

La Roche Posay Laboratoire Dermatologique Anthelios AOX Daily Antioxidant Serum Broad Spectrum SPF 50 Sunscreen by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Anthelios AOX Daily Antioxidant Serum Broad Spectrum SPF 50 Sunscreen 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 2.68%

Homosalate 9.6%

Octisalate 2.88%

Octocrylene 5.38%

Oxybenzone 3.46%

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:

• shake well before use
• apply generously 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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, dimethicone, cyclopentasiloxane, tocopherol, acrylates/dimethicone copolymer, phenoxyethanol, propylene glycol, caprylyl glycol, silica, sodium polyacrylate, ascorbyl glucoside, scutellaria baicalensis root extract, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, diethylhexyl syringylidenemalonate, polyacrylamide, C13-14 isoparaffin, laureth-7, cassia alata leaf extract, maltodextrin, 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 AOX DAILY ANTIOXIDANT SERUM BROAD SPECTRUM SPF 50 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-370
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	26.8 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	96 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	28.8 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	53.8 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	34.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
LAURETH-7 (UNII: Z95S6G8201)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-370-01	1 in 1 CARTON	01/01/2015
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-370-02	3 mL in 1 PACKET; Type 0: Not a Combination Product	01/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2015

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-370)