LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 ULTRA LIGHT SUNSCREEN BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES- avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray

La Roche Posay Laboratoire Dermatologique Anthelios 60 Ultra Light Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Anthelios 60 Ultra Light Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, American Spraytech, LLC, L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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.
• keep away from face to avoid breathing it

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:

●  spray generously and spread evenly by hand 15 minutes before sun exposure

● hold container 4 to 6 inches from the 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

● 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, 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?

1-888-LRP-LABO  1-888-577-5226

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 ULTRA LIGHT SUNSCREEN BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-008
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 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	96 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	28.8 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	53.8 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	34.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-008-01	143 g in 1 BOTTLE, SPRAY; 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 not final	part352	01/01/2014

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Accra Pac, Inc.		024213616	manufacture(49967-008)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		960317444	manufacture(49967-008)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-008)