PREVENTION DAILY TINTED MOSITURIZER OIL-FREE TINTED 30- zinc oxide and titanium dioxide cream 
Allure Labs, 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:
Zinc Oxide - 6.0%
Titanium Dioxide 4.6%

Purpose: Sunscreen

Uses:

Warnings

For External Use Only

if severe skin irritation develops

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

Directions

Aqua, Cyclopentasiloxane, Plankton Extract, Hexyl Triethoxysilylethyl, Polydimethylsiloxyethyl Dimethicone, Cyclohexasiloxane, Dimethicone/PEG-10/15 Crosspolymer, Arabidopsis Extract, Dimethicone/Polyglycerin -3 Crosspolymer, Aluminum Hydroxide Stearic Acid, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Sodium Chloride, Cetearyl Olivate, Tetrahexyldecyl Ascorbate, Micrococcus Lysate, Lecithin, Tocopheryl Acetate, Caprylyl Glycol, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Iron Oxide (CI77491, CI77492, CI77499)

Image International Palm Beach, FL 33462 USA www.imageskincare.com

ImagePDT306ImagePDT30

PREVENTION DAILY TINTED MOSITURIZER OIL-FREE TINTED 30 
zinc oxide and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4067
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE60 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE46 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4067-21 in 1 CARTON
1NDC:62742-4067-191 g in 1 TUBE
2NDC:62742-4067-3170 g in 1 TUBE
3NDC:62742-4067-47 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/09/2014
Labeler - Allure Labs, Inc (926831603)

Revised: 5/2014
Document Id: e200363c-eb83-4b5d-be27-390b206852f9
Set id: 03502b61-634f-430f-8e99-00dc2788fe39
Version: 1
Effective Time: 20140509
 
Allure Labs, Inc