Label: COTZ SPF 35- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58892-118-01 - 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 June 7, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- Active Ingredients:
- Purpose
- Uses
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Warnings
- For external use only
- Avoid contact with eyes. In case of eye contact, flush eyes with water thoroughly
- Do not use if sensitive to ingredients
- Discontinue use if irritation occurs. Consult a doctor or healthcare professional if irritation persists
- For use on children less than 6 months of age, consult a doctor
- Keep this and all medications out of the reach of children
- If swallowed, get medical help or contact a Poison Control Center
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Directions
- Apply generously and uniformly to all exposed skin areas before exposure to sunlight
- Continue to rub in until fading occurs, especially in hair bearing areas
- Reapply as needed and after washing, swimming, towel drying, or sweating for maximum protection.
Other Information
- Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
- May stain some fabrics
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Inactive Ingredients:
C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/VinyI Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane,
Manufactured
exclusively for
Fallene, Ltd.
West Norriton, PA 19403
Made in USA - Principal Display Panel – 3.5oz Carton Label
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INGREDIENTS AND APPEARANCE
COTZ SPF 35 SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-118 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 200 mg in 1 g Inactive Ingredients Ingredient Name Strength Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Caprylhydroxamic Acid (UNII: UPY805K99W) Caprylyl Glycol (UNII: 00YIU5438U) Cyclomethicone 6 (UNII: XHK3U310BA) Cyclomethicone 5 (UNII: 0THT5PCI0R) Dimethicone (UNII: 92RU3N3Y1O) Edetate Disodium (UNII: 7FLD91C86K) Glycerin (UNII: PDC6A3C0OX) Hydroxystearic Acid (UNII: 933ANU3H2S) Polysorbate 20 (UNII: 7T1F30V5YH) Sodium Chloride (UNII: 451W47IQ8X) Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) .Alpha.-Tocopherol Acetate, D- (UNII: A7E6112E4N) Trolamine (UNII: 9O3K93S3TK) Triethoxycaprylylsilane (UNII: LDC331P08E) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58892-118-01 1 in 1 CARTON 1 100 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2011 Labeler - Fallien Cosmeceuticals, LTD. (958388357) Establishment Name Address ID/FEI Business Operations Process Technologies & Packaging 809172885 MANUFACTURE, PACK Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 ANALYSIS Establishment Name Address ID/FEI Business Operations Harmony Labs Inc 105803274 MANUFACTURE, PACK
