Label: INVINCIBLE SETTING POWDER SPF 45 LIGHT- zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-146-01, 75936-146-02 - Packager: TAYLOR JAMES, LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 15, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- apply generously and evenly 15 minutes before sun exposure
- reapply
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- 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 value of 15 or higher and other sun protections measures including:
- Limit time in the sun, especially from 10a.m. -2p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
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INACTIVE INGREDIENT
Inactive Ingredients
Calcium Aluminum Borosilicate, Silica, Polymethyl Methacrylate, Ethylhexylglycerin, Triethoxycaprylysilane, Nylon-6/12, Sodium Dehydroacetate, Olive Glycerides, Ascorbyl Palmitate, Ceramide 3. May contain +/- Iron Oxides (CI 77492, CI 77491, CI 77499), Titanium Dioxide (CI 77891)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INVINCIBLE SETTING POWDER SPF 45 LIGHT
zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-146 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 24.5 g in 100 g Inactive Ingredients Ingredient Name Strength CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) ASCORBYL PALMITATE (UNII: QN83US2B0N) CERAMIDE 3 (UNII: 4370DF050B) Other Ingredients Ingredient Kind Ingredient Name Quantity May contain FERRIC OXIDE RED (UNII: 1K09F3G675) May contain FERRIC OXIDE YELLOW (UNII: EX438O2MRT) May contain FERROSOFERRIC OXIDE (UNII: XM0M87F357) May contain TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-146-02 1 in 1 BOX 01/15/2018 1 NDC:75936-146-01 4.25 g in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/15/2018 Labeler - TAYLOR JAMES, LTD. (033381850) Establishment Name Address ID/FEI Business Operations Kolmar Laboratories, Inc. 001535103 manufacture(75936-146)
