VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30 59ML- 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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Dosage

Inactive

Indications

OTC- Purpose

OTC - Active

OTC - Children

Safety Warnings

warnings

Principle Display Panel

59ml PDP

VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30 59ML 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45634-254
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.48 g  in 59 g
Inactive Ingredients
Ingredient NameStrength
LEVOMENOL (UNII: 24WE03BX2T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
XANTHAN GUM (UNII: TTV12P4NEE)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
THIOCTIC ACID (UNII: 73Y7P0K73Y)  
PHOSPHOLIPASE D1 (UNII: RO5LD48GLV)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
TOCOPHEROL (UNII: R0ZB2556P8)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45634-254-2082 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/28/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02007/28/2022
Labeler - N.V Perricone LLC (054414243)
Establishment
NameAddressID/FEIBusiness Operations
Dimensional Merchandising Inc (DMI)076693183manufacture(45634-254)

Revised: 7/2023
Document Id: 00235822-ef50-6fb5-e063-6394a90a0864
Set id: e4e0dc64-fa1e-3e00-e053-2a95a90a54b7
Version: 3
Effective Time: 20230710
 
N.V Perricone LLC