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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

image of a label

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-361
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE60 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE31 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-361-011 in 1 CARTON09/25/201509/20/2019
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/25/201509/20/2019
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.624244349manufacture(49967-361)

Revised: 1/2023
 
L'Oreal USA Products Inc