LAURA MERCIER TINTED MOISTURIZER - ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN - BARE RADIANCE- avobenzone, octinoxate cream 
Gurwitch Products, L.L.C.

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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Laura Mercier Tinted Moisturizer - Illuminating Broad Spectrum SPF 20 Sunscreen - Bare Radiance

Drug Facts

Active Ingredient

Avobenzone (2.0%), Octinoxate (7.5%)

Purpose

Sunscreen

Uses

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.

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

Other information

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

water, dimethicone, mica, cetearyl alcohol, hydrogenated polyisobutene, xylitylglucoside, PEG-40 castor oil, polyglyceryl-4 isostearate, cyclopentasiloxane, potassium cetyl phosphate, hexyl laurate, anhydroxylitol, tocopheryl acetate, cetyl PEG/PPG-10/1 dimethicone, xylitol, polysorbate 60, phenoxyethanol, butylene glycol, tribhenin, sodium dehydroacetate, sodium hyaluronate, allantoin, camellia sinensis leaf extract, copper gluconate, carbomer, hydrogenated olive oil, butyrospermum parkii (shea) butter, aminomethyl propanol, tetrasodium edta, magnesium aluminum silicate, sodium ascorbate, dipotassium glcyrrhizate, tin oxide, may contain: titanium dioxide, iron oixides.

Questions or comments?

Call 1-888-637-2437, M - F 9am - 5 pm CST.

Product Labels

TubeOuter Package

LAURA MERCIER TINTED MOISTURIZER - ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN - BARE RADIANCE 
avobenzone, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65342-1396
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MICA (UNII: V8A1AW0880)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ANHYDROXYLITOL (UNII: 8XWR7NN42F)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
XYLITOL (UNII: VCQ006KQ1E)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ALLANTOIN (UNII: 344S277G0Z)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
COPPER GLUCONATE (UNII: RV823G6G67)  
HYDROGENATED OLIVE OIL (UNII: 53839415GI)  
SHEANUT OIL (UNII: O88E196QRF)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
EDETATE SODIUM (UNII: MP1J8420LU)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
SODIUM ASCORBATE (UNII: S033EH8359)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65342-1396-050 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 finalpart35211/29/2010
Labeler - Gurwitch Products, L.L.C. (884875246)
Establishment
NameAddressID/FEIBusiness Operations
Atlantis Laboratories, Inc.194673984manufacture(65342-1396)
Establishment
NameAddressID/FEIBusiness Operations
Beauty Manufacturing Solutions Corp.783200723pack(65342-1396)

Revised: 7/2015
Document Id: 861b51a4-37e3-4f83-b81c-1047164d1d6e
Set id: 10cf5b44-3a12-4b98-b0f6-34b9c22827f9
Version: 2
Effective Time: 20150714
 
Gurwitch Products, L.L.C.