Label: TIZO PHOTOCEUTICAL AM REPLENISH NON-TINTED- zinc oxide cream
- NDC Code(s): 58892-107-50
- Packager: Fallien Cosmeceuticals, LTD
- Category: HUMAN OTC DRUG LABEL
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:
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Uses:
Helps prevents 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.
- Use a water resistant product if swimming or sweating.
- Reapply:
- -
- 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:
- -
- 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:
Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Hydrogen Dimethicone Silsesquioxane Crosspolymer
- Other Information:
- Principal Display Panel – Carton Label
- Principal Display Panel – Tube Label
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INGREDIENTS AND APPEARANCE
TIZO PHOTOCEUTICAL AM REPLENISH NON-TINTED
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-107 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 160 mg in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CERAMIDE NP (UNII: 4370DF050B) Cyclomethicone 6 (UNII: XHK3U310BA) Cyclomethicone 5 (UNII: 0THT5PCI0R) Dimethicone 20 (UNII: H8YMB5QY0D) Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane) (UNII: UF7620L1W6) Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5) Dimethiconol (2000 CST) (UNII: T74O12AN6Y) Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N) PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58892-107-50 1 in 1 CARTON 07/23/2019 1 50 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 03/05/2018 Labeler - Fallien Cosmeceuticals, LTD (958388357) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 ANALYSIS(58892-107) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing Inc. (FMI) 793406000 MANUFACTURE(58892-107) , PACK(58892-107)
