NO MAKEUP BRONZER SPF15- zinc oxide liquid 
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

Actives

Inactives

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Children

Purpose

Base Label

PDP

NO MAKEUP BRONZER SPF15 
zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45634-711
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.38 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C)  
ISODODECANE (UNII: A8289P68Y2)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ETHYL FERULATE (UNII: 5B8915UELW)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERROUS OXIDE (UNII: G7036X8B5H)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
XYLITOL (UNII: VCQ006KQ1E)  
CAPRYLIC ACID (UNII: OBL58JN025)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
MICA (UNII: V8A1AW0880)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ALPINIA OFFICINARUM LEAF (UNII: 8584IDD6OR)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45634-711-0313.9 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/03/2022
Labeler - N.V Perricone LLC (054414243)
Establishment
NameAddressID/FEIBusiness Operations
Dimensional Merchandising Inc (DMI)076693183manufacture(45634-711)

Revised: 7/2023
Document Id: 00232275-64d4-9d37-e063-6294a90a1acb
Set id: de1de12b-7c09-dd58-e053-2a95a90a6390
Version: 2
Effective Time: 20230710
 
N.V Perricone LLC