(GLOW)SETTING 100% MINERAL POWDER SPF 35- zinc oxide powder 
Supergoop, LLC

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.

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(Glow)Setting 100% Mineral Powder SPF 35

(Glow)setting 100% Mineral Powder

Zinc Oxide 2.4% Sunscreen

Uses

Stop use and ask a doctor if rash occurs

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 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)

(Glow)Setting 100% Mineral Powder

SPF 35

Broad Spectrum Sunscreen

0.13 oz. / 3.7 g.

Carton

(GLOW)SETTING 100% MINERAL POWDER SPF 35 
zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-603
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-603-021 in 1 BOX10/18/2022
1NDC:75936-603-013.7 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02010/18/2022
Labeler - Supergoop, LLC (117061743)

Revised: 10/2022
Document Id: eb556291-8de6-6bc4-e053-2a95a90a1494
Set id: eb556291-8de5-6bc4-e053-2a95a90a1494
Version: 1
Effective Time: 20221018
 
Supergoop, LLC