Label: PELLE WELLNESS SPF 50 FACE AND BODY BROAD SPECTRUM MINERAL SUNSCREEN- titanium dioxide, zinc oxide cream
- NDC Code(s): 83625-101-32
- Packager: Pelle Wellness LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 26, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
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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.
- For external use only
- Do not use on damaged or broken skin
- When using this product Keep out of eyes. Rinse with water to remove.
- Stop use and ask doctor if rash occurs.
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- STORAGE AND HANDLING
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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?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PELLE WELLNESS SPF 50 FACE AND BODY BROAD SPECTRUM MINERAL SUNSCREEN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83625-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:83625-101-32 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/26/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 08/26/2023 Labeler - Pelle Wellness LLC (063980271)