Label: COTZ PURE SPF 30 SUNSCREEN- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58892-600-01 - 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 December 18, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients:
- Purpose
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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:
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Directions:
- Apply liberally 15 minutes before sun exposure.
- Reapply:
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- After 40 minutes of swimming or sweating
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- Immediately after towel drying
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- At least every 2 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:
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- Limit time in the sun, especially from 10 a.m. - 2 p.m.
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- Wear long-sleeved shirts, pants, hats, and sunglasses
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Inactive Ingredients:
Brassica Campestris/Aleurites Fordii Oil Copolymer1 (from rapeseed and aleurites oils), Butyrospermum Parkii (Shea) Butter1 (shea tree extract), Camellia Oleifera Leaf Extract1 (Japanese green tea), Capric/Caprylic Triglyceride1,2,3(from coconut), Cellulose Gum1(from plant), Cetearyl Alcohol1,2,3(from coconut/ palm), Cetearyl Glucoside1,2,3(from coconut/palm and glucose sugar), Citric Acid (from citrus fruit), Glyceryl Caprylate1,2(from coconut), Glyceryl Undecylenate1,2(from castor bean and coconut glycerin), Iron Oxide1 (CI 77491) (natural mineral), Melissa Officinalis (Balm Mint) Extract1 (natural herb), Microcrystalline Cellulose1 (from wood pulp), Polyhydroxystearic Acid2(from castor plant), Rosmarinus Officinalis (Rosemary) Extract1 (natural herb), Salvia Officinalis (Sage) Leaf Extract1 (natural herb), Simmondsia Chinensis (Jojoba) Esters1,2(from natural plant) Sodium Stearoyl Glutamate1,2,3(from coconut and amino acid), Sorbitan Oleate Decylglucoside Crosspolymer4(from sugar and plant derived oleic acid), Xanthan Gum1(from plant sugar), Water
- Other Information:
- Principal Display Panel – SPF 30 85g Carton Label
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INGREDIENTS AND APPEARANCE
COTZ PURE SPF 30 SUNSCREEN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-600 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 41 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 84 mg in 1 g Inactive Ingredients Ingredient Name Strength Shea Butter (UNII: K49155WL9Y) Camellia Oleifera Leaf (UNII: 5077EL0C60) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Carboxymethylcellulose Sodium (UNII: K679OBS311) Cetostearyl Alcohol (UNII: 2DMT128M1S) Cetearyl Glucoside (UNII: 09FUA47KNA) Anhydrous Citric Acid (UNII: XF417D3PSL) Glyceryl Caprylate (UNII: TM2TZD4G4A) Ferric Oxide Red (UNII: 1K09F3G675) Melissa Officinalis (UNII: YF70189L0N) Cellulose, Microcrystalline (UNII: OP1R32D61U) Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F) Rosemary (UNII: IJ67X351P9) Sage (UNII: 065C5D077J) Sodium Stearoyl Glutamate (UNII: 65A9F4P024) Xanthan Gum (UNII: TTV12P4NEE) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58892-600-01 1 in 1 CARTON 1 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/14/2012 Labeler - Fallien Cosmeceuticals, LTD. (958388357) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 ANALYSIS(58892-600) Establishment Name Address ID/FEI Business Operations Process Technologies & Packaging 809172885 MANUFACTURE(58892-600) , PACK(58892-600)