Label: (GLOW)SETTING 100% MINERAL POWDER SPF 35- zinc oxide powder
- NDC Code(s): 75936-603-01, 75936-603-02
- 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 18, 2022
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- Official Label (Printer Friendly)
- (Glow)setting 100% Mineral Powder
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Directions
• apply generously and evenly 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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
• Children under 6 months: Ask a doctor
- WARNINGS
-
INACTIVE INGREDIENT
Inactive Ingredients
Synthetic Fluorphlogopite, Silica, Trimethylsiloxysilicate, Calcium Aluminum Borosilicate, Polymethyl Methacrylate, Calcium Sodium Borosilicate, Boron Nitride, Polyglyceryl-10 Pentaisostearate, Lauroyl Lysine, Triethoxycaprylylsilane, Ethylhexylglycerin, Water (Aqua), Nylon-12, Propanediol, Sodium Dehydroacetate, Oryza Sativa (Rice) Bran Extract, Aletris Farinosa Root Extract, Ascorbyl Palmitate, Helianthus Annuus (Sunflower) Seed Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Titanium Dioxide (Cl 77891), Iron Oxides (Cl 77492, 77491, 77499)
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
(GLOW)SETTING 100% MINERAL POWDER SPF 35
zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-603 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 24.9 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM DEHYDROACETATE (UNII: 8W46YN971G) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) NYLON-12 (UNII: 446U8J075B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) BORON NITRIDE (UNII: 2U4T60A6YD) LAUROYL LYSINE (UNII: 113171Q70B) PROPANEDIOL (UNII: 5965N8W85T) ALETRIS FARINOSA ROOT (UNII: O021JGR97X) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERRICLATE CALCIUM SODIUM (UNII: U7G9U9300W) POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ORYZA SATIVA WHOLE (UNII: 84IVV0906Z) ASCORBYL PALMITATE (UNII: QN83US2B0N) TOCOPHEROL (UNII: R0ZB2556P8) ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-603-02 1 in 1 BOX 10/18/2022 1 NDC:75936-603-01 3.7 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 10/18/2022 Labeler - Supergoop, LLC (117061743)
