HIGH POTENCY CLASSICS FACE FINISHING AND FIRMING TINTED MOISTURIZER SPF 30- titanium dioxide cream 
N.V Perricone LLC

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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inactive ingredients

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HIGH POTENCY CLASSICS FACE FINISHING AND FIRMING TINTED MOISTURIZER SPF 30 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45634-137
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.478 g  in 59 g
Inactive Ingredients
Ingredient NameStrength
ISOHEXADECANE (UNII: 918X1OUF1E)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HYDROGENATED SOYBEAN PHOSPHATIDYLCHOLINE (UNII: QHQ97HF0PY)  
THIOCTIC ACID (UNII: 73Y7P0K73Y)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
MANNITOL (UNII: 3OWL53L36A)  
.BETA.-BISABOLOL (UNII: LP618AV2EA)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ACETYL TETRAPEPTIDE-9 (UNII: VMO8OOD3V0)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45634-137-2082 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02004/04/2022
Labeler - N.V Perricone LLC (054414243)
Establishment
NameAddressID/FEIBusiness Operations
Dimensional Merchandising Inc (DMI)076693183manufacture(45634-137)

Revised: 7/2023
Document Id: 0022e63f-612d-29f0-e063-6294a90aff98
Set id: dbd72048-41db-7302-e053-2995a90a50b2
Version: 2
Effective Time: 20230710
 
N.V Perricone LLC