Label: POOF 100% MINERAL PART POWDER SPF 35- zinc oxide powder
- NDC Code(s): 75936-214-01
- Packager: Supergoop, LLC
- 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 October 19, 2022
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- 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
- use a water resistant sunscreen if swimming or sweating
- reapply 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 SPF value of 15 or higher and other sun
protection measures including:• limit your time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months of age: ask a doctor.
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INACTIVE INGREDIENT
Inactive ingredients
Calcium Aluminum Borosilicate, Silica, Trimethylsiloxysiloxysilicate, Calcium Sodium Borosilicate, Polymethyl Methacryate, Lauroyl Lysine, Polyglyceryl-10 Pentaisostearate, Boron Nitride, Triethoxycaprylysilane, Ethylhexylglycerin, Nylon-6/12, Sodium Dehydroacetate, Olive Glycerides, Ascorbyl Palmitate, Ceramide 3, Iron Oxides (CI 77492, 77491, 77499)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
POOF 100% MINERAL PART POWDER SPF 35
zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-214 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 24.7 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701) LAUROYL LYSINE (UNII: 113171Q70B) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) ASCORBYL PALMITATE (UNII: QN83US2B0N) CERAMIDE NP (UNII: 4370DF050B) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) BORON NITRIDE (UNII: 2U4T60A6YD) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-214-01 20 g in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/01/2020 Labeler - Supergoop, LLC (117061743)
