Label: TIZO MINERAL STICK NON-TINTED SPF 45- titanium dioxide, zinc oxide stick
- NDC Code(s): 58892-123-30
- Packager: Fallien Cosmeceuticals, LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 23, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients:
- Purpose:
-
Uses:
Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings:
-
Directions:
Apply liberally 15 minutes before sun exposure.
- Reapply:
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- 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 Ingredients:
Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Ethylene Brassylate, EthylhexI Palmitate, Helianthus Annuus (Sunflower) Wax, Hexyldecanol, Hexyldecyl Laurate, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Propylene Glycol Dicaprylate/Dicaprate, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil
- Other Information:
- Principal Display Panel – 30 g Carton Label
-
INGREDIENTS AND APPEARANCE
TIZO MINERAL STICK NON-TINTED SPF 45
titanium dioxide, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 40 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 55 mg in 1 g Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM STEARATE (UNII: U6XF9NP8HM) ASCORBIC ACID (UNII: PQ6CK8PD0R) ASCORBYL PALMITATE (UNII: QN83US2B0N) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETEARYL ISONONANOATE (UNII: P5O01U99NI) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD) DIPROPYLENE GLYCOL CAPRYLATE (UNII: CJ981S4H3T) ETHYLHEXYL PALMITATE (UNII: 2865993309) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYLDECANOL (UNII: 151Z7P1317) HEXYL LAURATE (UNII: 4CG9F9W01Q) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) CERESIN (UNII: Q1LS2UJO3A) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GINGER OIL (UNII: SAS9Z1SVUK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58892-123-30 1 in 1 CYLINDER 07/01/2022 1 30 g in 1 CYLINDER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/01/2022 Labeler - Fallien Cosmeceuticals, LTD (958388357) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 ANALYSIS(58892-123) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing Inc. (FMI) 793406000 MANUFACTURE(58892-123) , PACK(58892-123)