Label: SHEET SPF 30 MINERAL- titanium dioxide, zinc oxide lotion
- NDC Code(s): 67226-2232-6
- Packager: Vivier Pharma Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 14, 2024
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- Product Facts
- Medicinal ingredients
- Uses
- Warnings
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Directions
Adults and children over 6 months of age:
- Apply liberally and evenly 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Sun Protection Measures: Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: - limits time in the sun, especially from 10 a.m.–2 p.m. ; and wear long-sleeved shirts, pants, hats, and sunglasses.
- Other information
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Non-medicinal ingredients
Alumina, Ammonium Acryloyldimethyltaurate/VP Copolymer, Bis-PEG/PPG-16/16 PEG/PPG-16/16 Dimethicone, Butylparaben, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Cetyl Dimethicone, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dipropylene Glycol Dibenzoate, DL-alpha Tocopheryl Acetate, Ethylparaben, Glycerin, Glyceryl Stearate, Green Tea Extract, Iron Oxides CI 77491, Iron Oxides CI 77492, Iron Oxides CI 77499, Isopropyl Titanium Triisostearate, Methylparaben, Phenoxyethanol, Phytic Acid, Polyhydroxystearic Acid, Polysorbate 20, PPG-15 Stearyl Ether Benzoate, Propylene Glycol, Propylparaben, Pyrus Malus (Apple) Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Sodium Ascorbyl Phosphate, Sodium Hydroxide, t-Butyl Alcohol, Triethoxycaprylylsilane, VP/Eicosene Copolymer, Water/Eau, Xanthan Gum.
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INGREDIENTS AND APPEARANCE
SHEET SPF 30 MINERAL
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67226-2232 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 100 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 80 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) SODIUM HYDROXIDE (UNII: 55X04QC32I) ALUMINUM OXIDE (UNII: LMI26O6933) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE (UNII: 55A74AJ3KB) BUTYLPARABEN (UNII: 3QPI1U3FV8) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ORANGE PEEL (UNII: TI9T76XD44) LEMON PEEL (UNII: 72O054U628) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) ETHYLPARABEN (UNII: 14255EXE39) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GREEN TEA LEAF (UNII: W2ZU1RY8B0) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) METHYLPARABEN (UNII: A2I8C7HI9T) PHENOXYETHANOL (UNII: HIE492ZZ3T) FYTIC ACID (UNII: 7IGF0S7R8I) POLYSORBATE 20 (UNII: 7T1F30V5YH) PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) APPLE (UNII: B423VGH5S9) SUGARCANE (UNII: 81H2R5AOH3) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67226-2232-6 1 in 1 BOX 01/04/2021 02/28/2027 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/04/2021 02/28/2027 Labeler - Vivier Pharma Inc. (250996550)
