PELLE WELLNESS SPF 50 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) - Face & Body Sunscreen SPF-50 (83625-101)

ACTIVE INGREDIENTS

ZINC OXIDE 7.0%

TITANIUM DIOXIDE 3.0%

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, Glycerin, Ethylhexyl Palmitate, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Propanediol, Sodium PCA, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 60, Cetyl Alcohol, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Citric
Acid, Sodium Citrate, Glyceryl Caprylate, Caprylyl Methicone, Alumina, Xanthan Gum, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Chlorphenesin, Cyclotetrasiloxane, Allantoin, Polyhydroxystearic Acid,
Triethoxycaprylylsilane, Glyceryl Undecylenate, 1,2-Hexanediol, Caprylyl Glycol, Disodium EDTA, Panthenol, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Euterpe Oleracea Fruit Extract, Sodium Hyaluronate, Phenoxyethanol

Questions or Comments?

call 626-877-8505

LBL

PELLE WELLNESS SPF 50 FACE AND BODY BROAD SPECTRUM MINERAL SUNSCREEN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83625-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CYCLOMETHICONE 4 (UNII: CZ227117JE)  
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
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)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
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)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PANTHENOL (UNII: WV9CM0O67Z)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)  
EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83625-101-321000 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: 03daacb3-750f-6176-e063-6394a90a2d4b
Set id: 03daacb3-750e-6176-e063-6394a90a2d4b
Version: 1
Effective Time: 20230826
 
Pelle Wellness LLC