PELLE WELLNESS SPF 30 FACE AND BODY BROAD SPECTRUM MINERAL SUNSCREEN- titanium dioxide, zinc oxide cream 
Pelle Wellness 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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Pelle Wellness (as PLD) - SPF 30 Face & Body Broad Spectrum Mineral Sunscreen (83625-102)

ACTIVE INGREDIENTS

ZINC OXIDE 6.0%

TITANIUM DIOXIDE 2.5%

PURPOSE

SUNSCREEN

USES

WARNINGS

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

DIRECTIONS

Children after 6 months: Ask a doctor

INACTIVE INGREDIENTS

Water, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Propanediol, C12-15 Alkyl Benzoate, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Cyclohexasiloxane, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Sucrose Cocoate, Citric Acid, Glyceryl Isostearate, Polyhydroxystearic Acid, Sodium Citrate, Sodium PCA, Caprylyl Methicone, Alumina, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Chlorphenesin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone,
Allantoin, Xanthan Gum, Glyceryl Undecylenate, Glycerin, Magnesium Ascorbyl Phosphate, Panthenol, Phytic Acid, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Phenoxyethanol, Sodium Hyaluronate

Questions or Comments?

call 626-877-8505

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PELLE WELLNESS SPF 30 FACE AND BODY BROAD SPECTRUM MINERAL SUNSCREEN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83625-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FYTIC ACID (UNII: 7IGF0S7R8I)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PROPANEDIOL (UNII: 5965N8W85T)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
ALLANTOIN (UNII: 344S277G0Z)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
PANTHENOL (UNII: WV9CM0O67Z)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83625-102-321000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02008/26/2023
Labeler - Pelle Wellness LLC (063980271)

Revised: 8/2023
Document Id: 03dd6f8e-5070-dffd-e063-6294a90a81cc
Set id: 03dd6ffb-d67f-a483-e063-6294a90a84e1
Version: 1
Effective Time: 20230826
 
Pelle Wellness LLC