Label: PROCEUTICALS PRIVATE LABEL BY TIZO TINTED FOAMING MINERAL SUNSCREEN- titanium dioxide, zinc oxide aerosol, foam
- NDC Code(s): 58892-210-01
- Packager: Fallien Cosmeceuticals, Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 30, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
DIRECTIONS:
• Shake well before using.
• Press nozzle carefully during first use
• Apply liberally 15 minutes before sun exposure.
• Reapply:
• After 40 minutes of swimming or sweating
• Immediately after towel drying
• At least every 2 hours
• Children under 6 months: Ask a doctor
• 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 value of 15 or higher and other sun
protection measures including:
• Limit time in the sun, especially from 10 am -2 pm
• Wear long-sleeved shirts, pants, hats, and sunglasses -
INACTIVE INGREDIENT
INACTIVE INGREDIENTS:
Bismuth Oxychloride, Butyloctyl Salicylate, C12-15 Alkyl Benzoate,
Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Ceteareth-20, Cetearyl
Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate,
Iron Oxides, Isododecane, Isohexadecane, Methyl Methacrylate Crosspolymer,
Mica, Microcrystalline Cellulose, Octyldodecyl Erucate, Octyldodecyl
Neopentanoate, Polymethyl Methacrylate, Polysorbate 80,
Trans-1,3,3,3-Tetrafluoropropene, Triacontanyl PVP, Triethoxycaprylylsilane,
Trimethoxycaprylylsilane, Water - OTHER SAFETY INFORMATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PROCEUTICALS PRIVATE LABEL BY TIZO TINTED FOAMING MINERAL SUNSCREEN
titanium dioxide, zinc oxide aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-210 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 30 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERETH-26 (UNII: NNE56F2N14) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) TRICONTANYL POVIDONE (UNII: N0SS3Q238D) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ISODODECANE (UNII: A8289P68Y2) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) OCTYLDODECYL ERUCATE (UNII: D4N66T98C2) 1,3,3,3-TETRAFLUOROPROPENE, (1E)- (UNII: 5I2481UOO8) POLYSORBATE 80 (UNII: 6OZP39ZG8H) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) MICA (UNII: V8A1AW0880) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) WATER (UNII: 059QF0KO0R) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) GLYCERIN (UNII: PDC6A3C0OX) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58892-210-01 100 g in 1 CAN; Type 0: Not a Combination Product 07/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/30/2024 Labeler - Fallien Cosmeceuticals, Ltd (958388357) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 analysis(58892-210) Establishment Name Address ID/FEI Business Operations Tri-Pac Inc 020844956 manufacture(58892-210)
