Label: TINTED MINERAL SUNSCREEN SPF-30- titanium dioxide, zinc oxide lotion
- NDC Code(s): 82069-101-12
- Packager: Buttah Enterprises, LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 5, 2023
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- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
- APPLY LIBERALLY AND EVENLY 15 MINUTES BEFORE SUN EXPOSURE
- REAPPLY AT LEAST EVERY 2 HOURS.
- USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
- SUN PROTECTION MEASURES: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD-SPECTRUM SPF OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
- LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 AM TO 2 PM.
- WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
- CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.
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INACTIVE INGREDIENTS
Water (Aqua), Caprylic/Capric Triglyceride, Cyclopentasiloxane, Propanediol, Dimethicone, Glycerin, C12-15 Alkyl Benzoate, PEG-100 Stearate, Glyceryl STearate, Cetyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Cyclohexasiloxane, Sucrose Cocoate, Citric Acid, Sodium Citrate, Sodium PCA, Glyceryl Isostearate, Alumina, Caprylyl Methicone, Polyhydroxystearic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, Chlorphenesin, Iron Oxides, Allantoin, Xanthan Gum, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Glyceryl Undecylenate, Panthenol, Phytic Acid, Sodium Hyaluronate.
- STORAGE AND HANDLING
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TINTED MINERAL SUNSCREEN SPF-30
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82069-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 6 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PROPANEDIOL (UNII: 5965N8W85T) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) CYCLOMETHICONE 6 (UNII: XHK3U310BA) SUCROSE COCOATE (UNII: 3H18P0UK73) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ALUMINUM OXIDE (UNII: LMI26O6933) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) DIMETHICONE 100 (UNII: RO266O364U) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) CHLORPHENESIN (UNII: I670DAL4SZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ALLANTOIN (UNII: 344S277G0Z) XANTHAN GUM (UNII: TTV12P4NEE) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02) CUCUMBER (UNII: YY7C30VXJT) GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544) PANTHENOL (UNII: WV9CM0O67Z) FYTIC ACID (UNII: 7IGF0S7R8I) HYALURONATE SODIUM (UNII: YSE9PPT4TH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82069-101-12 60 mL in 1 TUBE; Type 0: Not a Combination Product 07/14/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/13/2021 Labeler - Buttah Enterprises, LLC. (117683150)