LOREAL PARIS ADVANCED SUNCARE SILKY SHEER BB FACE 50 PLUS BROAD SPECTRUM SPF 50 PLUS SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

LOreal Paris Advanced Suncare Silky Sheer BB Face 50 Plus Broad Spectrum SPF 50 Plus Sunscreen by

Drug Labeling and Warnings

LOreal Paris Advanced Suncare Silky Sheer BB Face 50 Plus Broad Spectrum SPF 50 Plus 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 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

Flammable until dry.

Do not use near fire, flame or heat.

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: (this statement is not always optional)

● shake well before use

● apply generously 15 minutes before sun exposure

● 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, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexasiloxane, polymethylsilsesquioxane, nylon-12, PEG-8 laurate, dicaprylyl carbonate, dodecene, sodium chloride, vitis vinifera (grape) fruit extract, aluminum hydroxide, phenoxyethanol, iron oxides, p-anisic acid, tocopherol, disodium EDTA, poloxamer 407, disodium stearoyl glutamate, lauryl PEG/PPG-18/18 methicone, caprylyl glycol, isostearyl alcohol, disteardimonium hectorite, poly C10-30 alkyl acrylate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS ADVANCED SUNCARE SILKY SHEER BB FACE 50 PLUS BROAD SPECTRUM SPF 50 PLUS SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-556
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)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-556-01	1 in 1 CARTON	12/20/2013
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	12/20/2013

Labeler - L’Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L’Oreal USA, Inc.		624244349	manufacture(49967-556)