HIGH POTENCY CLASSICS Face Finishing and Firming Tinted Moisturizer SPF 30 by N.V Perricone LLC / Dimensional Merchandising Inc (DMI)

HIGH POTENCY CLASSICS Face Finishing and Firming Tinted Moisturizer SPF 30 by

Drug Labeling and Warnings

HIGH POTENCY CLASSICS Face Finishing and Firming Tinted Moisturizer SPF 30 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]

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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HIGH POTENCY CLASSICS FACE FINISHING AND FIRMING TINTED MOISTURIZER SPF 30 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45634-137
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.478 g  in 59 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45634-137-20	82 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/04/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	04/04/2022

Labeler - N.V Perricone LLC (054414243)

Establishment
Name	Address	ID/FEI	Business Operations
Dimensional Merchandising Inc (DMI)		076693183	manufacture(45634-137)

Revised: 7/2023

Document Id: 0022e63f-612d-29f0-e063-6294a90aff98

34390-5

Set id: dbd72048-41db-7302-e053-2995a90a50b2

Version: 2

Effective Time: 20230710