Label: SOLAR PROTECTION FORMULA TIZO BODY SUNSCREEN - zinc oxide cream
- NDC Code(s): 58892-218-01
- 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.
Updated September 2, 2010
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- SPL UNCLASSIFIED SECTION
- Active Ingredients:
Zinc Oxide 20%Close
- Helps prevent sunburn
- Provides protection from UVA & UVB rays that may contribute to premature aging of the skin
- Retains SPF up to 40 minutes of water immersion or perspiring
- 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 medicines out of the reach of children
- If swallowed, get medical help or contact a Poison Control Center
- 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
- Inactive Ingredients:
C12-15 Alkyl Benzoate, Caprylhydroxyamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl 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, Triethoxycaprylysilane, Water
TiZO Body SPF 35 is a sunscreen uniquely formulated to offer sheer, elegant protection with a silky, smooth, matte finish. TiZO Body offers unparalleled aesthetic elegance while providing superb photoprotective performance. Using our proprietary technology, Fallien has formulated multiple particle sizes of micronized zinc oxide into a light, silky texture that dries to a clear, yet matte finish on any complexion. TiZO Body is paraben, oil and fragrance free, and specially formulated without UV absorbing chemicals to offer unsurpassed, irritant free UVA/UVB light protection.Close
- SPF is not Enough
UVA radiation is consistently the same all day and all year long. Everyone requires daily, year round UVA protection. UVA radiation is responsible for deep skin damage that results in most of the changes associated with skin aging, such as wrinkling. In addition, the effects of UVA damage are cumulative. Since the SPF number does not define the level of UVA protection, products that utilize both titanium dioxide and/or zinc oxide, are the best method of assuring full spectrum sun protection from UVA and UVB radiation.
- Excellent for Sensitive Skin
- Free of "Chemical Sunscreen Filters"
- Contains no Parabens
- Dries Translucent
- Full Spectrum Protection
- Fragrance Free
Manufactured exclusively forClose
West Norriton PA 19403
Made in USA
- Principal Display Panel – Carton Label
20% Zinc Oxide Mineral Protection
Net Wt 3.5 oz. / 100gClose
- INGREDIENTS AND APPEARANCE
SOLAR PROTECTION FORMULA TIZO BODY SUNSCREEN
zinc oxide cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-218 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 C12-15 Alkyl 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) Octyltriethoxysilane (UNII: LDC331P08E) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58892-218-01 1 in 1 CARTON 1 100 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2010 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