Lancome Paris Flash Bronzer AntiAge Tinted AntiAge Self Tanning Face SPF 15 by L'Oreal USA Products Inc Drug Facts

Lancome Paris Flash Bronzer AntiAge Tinted AntiAge Self Tanning Face SPF 15 by

Drug Labeling and Warnings

Lancome Paris Flash Bronzer AntiAge Tinted AntiAge Self Tanning Face SPF 15 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LANCOME PARIS FLASH BRONZER ANTIAGE TINTED ANTIAGE SELF TANNING FACE SPF 15- avobenzone, homosalate, octisalate and octocrylene lotion 
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

Avobenzone 3%

Homosalate 2%

Octisalate 5%

Octocrylene 7%

Directions

Apply before sun exposure. For best results, exfoliate skin first. Apply product evenly - blend well using circular motions. Carefully blur hairline and eyebrows with a moistened cotton pad. Avoid contact with eyes, hair and clothing. Wash hands thoroughly after use. To maintain color, reapply 2 - 3 times a week.

Storage

PLEASE STORE AWAY FROM EXTREME HEAT.

Warnings

FOR EXTERNAL USE ONLY. 

When using this product

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

Stop use and ask a doctor if

RASH OR IRRITATION DEVELOPS AND LASTS.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Inactive ingredients

WATER
GLYCERIN
C12-15 ALKYL BENZOATE
DIHYDROXYACETONE
ALCOHOL DENAT.
PROPYLENE GLYCOL
DIMETHICONE
ISOHEXADECANE
CARAMEL
STYRENE/ACRYLATES COPOLYMER
TRI-C14-15 ALKYL CITRATE
ARACHIDYL ALCOHOL
SODIUM POLYACRYLOYLDIMETHYL TAURATE
PEG-100 STEARATE
GLYCERYL STEARATE
MICA
BEHENYL ALCOHOL
FRAGRANCE
PHENOXYETHANOL
DIMETHICONOL
ARACHIDYL GLUCOSIDE
ETHYLPARABEN
TITANIUM DIOXIDE
METHYLPARABEN
POLYSORBATE 80
DISODIUM EDTA
METHYLSILANOL MANNURONATE
HEXYL CINNAMAL
TOCOPHEROL
SORBITAN OLEATE
BENZYL ALCOHOL
BENZYL SALICYLATE
BUTYLPHENYL METHYLPROPIONAL
LINALOOL
CITRONELLOL
YELLOW 6
ALPHA-ISOMETHYL IONONE
HYDROXYCITRONELLAL
GERANIOL
LIMONENE
RED 33
EUGENOL

LANCOME PARIS FLASH BRONZER ANTIAGE TINTED ANTIAGE SELF TANNING FACE SPF 15 
avobenzone, homosalate, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-860
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	20 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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIHYDROXYACETONE (UNII: O10DDW6JOO)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOHEXADECANE (UNII: 918X1OUF1E)
CARAMEL (UNII: T9D99G2B1R)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
PEG-100 STEARATE (UNII: YD01N1999R)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ETHYLPARABEN (UNII: 14255EXE39)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TOCOPHEROL (UNII: R0ZB2556P8)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
GERANIOL (UNII: L837108USY)
EUGENOL (UNII: 3T8H1794QW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-860-01	1 in 1 CARTON	06/01/2010	03/13/2015
1		50 mL in 1 BOTTLE, PUMP; 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	06/01/2010	03/13/2015

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products Inc		185931458	manufacture(49967-860)

Revised: 1/2020

Document Id: e374d8fb-5712-4504-957e-ec44ab7246cc

34390-5

Set id: 2f2c8902-e001-4a17-aa70-3755989b2cf9

Version: 4

Effective Time: 20200117

 

L'Oreal USA Products Inc