VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30 15mL by N.V Perricone LLC / Dimensional Merchandising Inc (DMI)

VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30 15mL by

Drug Labeling and Warnings

VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30 15mL by is a Otc medication manufactured, distributed, or labeled by N.V Perricone LLC, Dimensional Merchandising Inc (DMI). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30 59ML 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45634-254
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.48 g  in 59 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45634-254-20	82 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	07/28/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	07/28/2022

Labeler - N.V Perricone LLC (054414243)

Establishment
Name	Address	ID/FEI	Business Operations
Dimensional Merchandising Inc (DMI)		076693183	manufacture(45634-254)

Revised: 7/2023

Document Id: 00235822-ef50-6fb5-e063-6394a90a0864

34390-5

Set id: e4e0dc64-fa1e-3e00-e053-2a95a90a54b7

Version: 3

Effective Time: 20230710