LOREAL PARIS SUBLIME BRONZE SUMMER EXPRESS WASH OFF FACE BRONZER BROAD SPECTRUM SPF 20 SUNSCREEN- homosalate, octisalate, octocrylene and titanium dioxide cream

LOreal Paris Sublime Bronze Summer Express Wash Off Face Bronzer Broad Spectrum SPF 20 Sunscreen by

Drug Labeling and Warnings

LOreal Paris Sublime Bronze Summer Express Wash Off Face Bronzer Broad Spectrum SPF 20 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

Homosalate 6%

Octisalate 5%

Octocrylene 7%

Titanium dioxide 3.1%

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.

Sstop 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 liberally 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, isononyl isononanoate, glycerin, dimethicone, alcohol denat., diisopropyl sebacate, sucrose tristearate, styrene/acrylates copolymer, polysorbate 61, sodium stearoyl glutamate, phenoxyethanol, PEG-12 dimethicone, caprylyl glycol, silica, carbomer, triethanolamine, dimethiconol, PEG-8 laurate, tocopheryl acetate, xanthan gum, disodium EDTA, benzyl salicylate, sodium hyaluronate, saccharomyces/xylinum/black tea ferment, benzyl alcohol, limonene, hydroxycitronellal, linalool, tin oxide, biosaccharide gum-1, butylphenyl methylpropional, citronellol, geraniol, citral, hydroxyethylcellulose, sodium citrate, coumarin, citric acid, potassium sorbate, biotin, fragrance; may contain: titanium dioxide, mica, iron oxides

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS SUBLIME BRONZE SUMMER EXPRESS WASH OFF FACE BRONZER BROAD SPECTRUM SPF 20 SUNSCREEN 
homosalate, octisalate, octocrylene and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-361
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	60 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	31   in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
SUCROSE TRISTEARATE (UNII: 71I93STU5M)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
POLYSORBATE 61 (UNII: X9E1MY2JQG)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
PEG-8 LAURATE (UNII: 762O8IWA10)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
STANNIC OXIDE (UNII: KM7N50LOS6)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
CITRAL (UNII: T7EU0O9VPP)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
COUMARIN (UNII: A4VZ22K1WT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BIOTIN (UNII: 6SO6U10H04)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-361-01	1 in 1 CARTON	09/25/2015
1		30 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	09/25/2015

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		624244349	manufacture(49967-361)