HYPOALLERGENIC CBD SENSITIVE SKIN THERAPY ULTRA-LIGHTWEIGHT CALMING VEIL SPF 35- zinc oxide cream 
NV 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 & Administration Section

OTC - ACTIVE INGREDIENT

INACTIVE INGREDIENTS

INDICATIONS & USAGE

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OTC PURPOSE

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HYPOALLERGENIC CBD SENSITIVE SKIN THERAPY ULTRA-LIGHTWEIGHT CALMING VEIL SPF 35 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45634-716
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.3175 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
CANNABIDIOL (UNII: 19GBJ60SN5)  
ROSEMARY (UNII: IJ67X351P9)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
LINGONBERRY (UNII: 0UNK9RZQ7X)  
CALCIUM GLUCONATE (UNII: SQE6VB453K)  
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
C9-12 ALKANE (UNII: 7J5R5W72QM)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
CASTOR OIL (UNII: D5340Y2I9G)  
RICE BRAN (UNII: R60QEP13IC)  
TRIHEPTANOIN (UNII: 2P6O7CFW5K)  
DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
STEAROYL GLUTAMIC ACID (UNII: 4R4O71786G)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PROPANEDIOL (UNII: 5965N8W85T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
LEVOMENOL (UNII: 24WE03BX2T)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45634-716-159.3 g in 1 TUBE; Type 0: Not a Combination Product09/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02009/05/2023
Labeler - NV Perricone LLC (054414243)
Establishment
NameAddressID/FEIBusiness Operations
Dimensional Merchandising Inc (DMI)076693183manufacture(45634-716)

Revised: 9/2023
Document Id: 04b1a617-e188-9f04-e063-6394a90a7c9c
Set id: 04b1a617-e187-9f04-e063-6394a90a7c9c
Version: 1
Effective Time: 20230906
 
NV Perricone LLC