Label: COTZ KIDS PURE BOTANICALS- titanium dioxide, zinc oxide cream
- NDC Code(s): 58892-603-04
- 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 January 12, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
- -
- At least every two hours
- Children under 6 months: Ask a doctor
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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 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
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Inactive Ingredients:
Butyrospermum Parkii (Shea) Butter (Shea Tree Extract), C12-15 Alkyl Benzoate (from Cranberries & Coconut), Camellia Sinensis (Green Tea) Leaf Extract, Capric/Caprylic Triglyceride (From Coconut), Glyceryl Caprylate (From Coconut), Glyceryl Undecylenate (From Castor Bean & Coconut), Melissa Officinalis (Balm Mint) Extract (Natural Herb), Olive Oil Polyglyceryl-6 Esters (From Glycerin & Olive Oil), Polyglyceryl-6 Pentaoleate (From Glycerin & Olive Oil), Polyhydroxystearic Acid (From Castor Plant), Propanediol (From Corn), Rosemarinus Officinalis (Rosemary) Extract (Natural Herb), Salvia Officinalis (Sage) Leaf Extract (Natural Herb), Sclerocarya Birrea (Marula) Seed Oil (Tree Fruit Extract), Simmondsia Chinensis (Jojoba) Esters (From Natural Plant), Sodium Chloride (Natural Mineral), Sodium Stearoyl Glutamate (From Coconut & Amino Acid), Tetradecane (Derived from Vegetable Oil), Tetrahexyldecyl Ascorbate (From Mixed Citrus and Palm Oil), Tocopherol (From Mixed Fruit & Seed Extracts), Tocopheryl Acetate (From Mixed Fruit & Seed Extracts), Water
- Other Information:
- Principal Display Panel – Carton Label
- Principal Display Panel – Tube Label
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INGREDIENTS AND APPEARANCE
COTZ KIDS PURE BOTANICALS
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-603 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 SHEA BUTTER (UNII: K49155WL9Y) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544) MELISSA OFFICINALIS (UNII: YF70189L0N) POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PROPANEDIOL (UNII: 5965N8W85T) ROSEMARY OIL (UNII: 8LGU7VM393) SAGE (UNII: 065C5D077J) SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2) SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) 1-TETRADECENE (UNII: FW23481S7S) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58892-603-04 1 in 1 CARTON 04/15/2019 1 113 g in 1 TUBE; 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 04/15/2019 Labeler - Fallien Cosmeceuticals, LTD (958388357) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 ANALYSIS(58892-603) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing Inc. (FMI) 793406000 MANUFACTURE(58892-603) , PACK(58892-603)