LAURA MERCIER FLAWLESS SKIN MEGA MOISTURE CREME BROAD SPECTRUM SPF 15 SUNSCREEN FOR NORMAL/DRY SKIN- 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 Flawless Skin Mega Moisture Creme Broad Spectrum SPF 15 Sunscreen for Normal/Dry Skin

Drug Facts

Active Ingredient

Avobenzone 2.0%

Octinoxate 7.5%

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, cyclopentasiloxane, dimethicone, polyglyceryl-4 isostearate, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, Emu oil, glycerin, sorbitol, cetearyl alcohol, peg-40 castor oil, tocopheryl acetate, potassium cetyl phosphate, petrolatum, polysorbate 60, urea, sodium hyaluronate, allantoin, sodium ascorbate, phenoxyethanol, methylparaben, tetrasodium EDTA, carbomer, isopropylparaben, isobutylparaben, butylparaben, sodium dehydroacetate, aminomethyl propanol, linalool, propylparaben, acrylates/c10-30 alkyl acrylate crosspolymer.

Questions or comments?

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

Product Labels

JarBottomCarton

LAURA MERCIER FLAWLESS SKIN MEGA MOISTURE CREME BROAD SPECTRUM SPF 15 SUNSCREEN FOR NORMAL/DRY SKIN 
avobenzone, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65342-0945
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
EMU OIL (UNII: 344821WD61)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
UREA (UNII: 8W8T17847W)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ALLANTOIN (UNII: 344S277G0Z)  
SODIUM ASCORBATE (UNII: S033EH8359)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
EDETATE SODIUM (UNII: MP1J8420LU)  
ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65342-0945-050 g in 1 JAR; 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(65342-0945)
Establishment
NameAddressID/FEIBusiness Operations
Beauty Manufacturing Solutions Corp.783200723pack(65342-0945)

Revised: 7/2015
Document Id: 0457d6da-3cc2-458f-b558-6ff0f7f44d1a
Set id: fc4806e4-234a-49fc-b205-c25f43db041d
Version: 2
Effective Time: 20150713
 
Gurwitch Products, L.L.C.