Label: MINERAL SPF STARTER KIT- titanium dioxide, zinc oxide kit
- NDC Code(s): 75936-610-01, 75936-611-01, 75936-612-01, 75936-613-01
- 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 January 1, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Mineral Sheerscreen SPF 30 Active Ingredients
- Mineral Mattescreen SPF 40 Active Ingredient
- Play Mineral Lotion SPF 30 Active Ingredients
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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Mineral Sheerscreen SPF 30
Apply generously and evenly as the last step in your skincare routine, before makeup and 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
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Mineral Mattescreen SPF 40
Directions
Apply generously and evenly as the last step in your skincare routine, before makeup and 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
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Play 100% Mineral Lotion SPF 30
Directions
• apply generously and evenly 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hoursSun 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
- KEEP OUT OF REACH OF CHILDREN
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Mineral Sheerscreen SPF 30
Inactive Ingredients: Water, Isododecane, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Propanediol, Glycerin, Squalane, Trioctyldodecyl Citrate, Polyglycerin-3, Polyglyceryl-3 Lactate/Laurate, Polysilicone-11, Cetearyl Alcohol, Glyceryl Stearate, Sodium Stearoyl Glutamate, Butylene Glycol, Xanthan Gum, Polyacrylate Crosspolymer-6, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Caprylhydroxamic Acid, Citric Acid, Aloe Barbadensis Leaf Juice, Lespedeza Capitata Leaf/Stem Extract, Maltodextrin, Sodium Hyaluronate
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Mineral Mattescreen SPF 40
Inactive Ingredients: Dimethicone, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Methyl Dihydroabietate, Polyhydroxystearic Acid, C9-12 Alkane, Glycerin, Iron Oxides (CI 77492), Ethylhexylglycerin, Water (Aqua), Coco-Caprylate/Caprate, Silica, Stearic Acid, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Hedychium Coronarium Root Extract, Lactobacillus/Arundinaria Gigantea Leaf Ferment Filtrate, Leuconostoc/Radish Root Ferment Filtrate, Titanium Dioxide (CI 77891)
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Play 100% Mineral Lotion SPF 30
Inactive Ingredients: Arachidyl Alcohol, Arachidyl Glucoside, Astrocaryum Vulgare Kernel Oil, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, C13-14 Alkane, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Diheptyl Succinate, Erythritol, Ethyl Ferulate, Glycerin, Haematococcus Pluvialis Extract, Jojoba Esters, Lauryl Laurate, Methyl Dihydroabietate, Microcrystalline Cellulose, Neopentyl Glycol Diheptanoate, Polyester-7, Polyester-8, Polyhydroxystearic Acid, Propanediol, Sea Water, Sodium Gluconate, Sodium Stearoyl Glutamate, Tocopherol, Water
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MINERAL SPF STARTER KIT
titanium dioxide, zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-610 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-610-01 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 01/01/2023 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 15 mL Part 2 1 TUBE 15 mL Part 3 1 TUBE 30 mL Part 1 of 3 MINERAL SHEERSCREEN SPF 30
zinc oxide creamProduct Information Item Code (Source) NDC:75936-611 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 17.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SQUALANE (UNII: GW89575KF9) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) XANTHAN GUM (UNII: TTV12P4NEE) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) MALTODEXTRIN (UNII: 7CVR7L4A2D) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) LESPEDEZA CAPITATA FLOWERING TOP (UNII: F930LFZ4LF) PROPANEDIOL (UNII: 5965N8W85T) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) POLYGLYCERYL-3 LAURATE (UNII: Y9ZSR39D0E) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) ISOSTEARIC ACID (UNII: X33R8U0062) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ISODODECANE (UNII: A8289P68Y2) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SODIUM CHLORIDE (UNII: 451W47IQ8X) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-611-01 15 mL 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 final M020 01/01/2023 Part 2 of 3 MINERAL MATTESCREEN SPF 40
titanium dioxide, zinc oxide creamProduct Information Item Code (Source) NDC:75936-612 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.33 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 17.42 g in 100 mL Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) GLYCERIN (UNII: PDC6A3C0OX) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) C9-11 ALKANE/CYCLOALKANE (UNII: 3EZ541F5MW) WATER (UNII: 059QF0KO0R) ARUNDINARIA GIGANTEA WHOLE (UNII: 0W60URK9Q6) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DIMETHICONE (UNII: 92RU3N3Y1O) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) TOCOPHEROL (UNII: R0ZB2556P8) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-612-01 15 mL 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 final M020 01/01/2023 Part 3 of 3 MINERAL BROAD SPECTRUM SUNSCREEN
zinc oxide creamProduct Information Item Code (Source) NDC:75936-613 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 16 g in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) COCO GLUCOSIDE (UNII: ICS790225B) ERYTHRITOL (UNII: RA96B954X6) GLYCERIN (UNII: PDC6A3C0OX) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DOCOSANOL (UNII: 9G1OE216XY) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) LEVOMENOL (UNII: 24WE03BX2T) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) TOCOPHEROL (UNII: R0ZB2556P8) DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PROPANEDIOL (UNII: 5965N8W85T) POLYESTER-7 (UNII: 0841698D2F) POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62) ETHYL FERULATE (UNII: 5B8915UELW) HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM GLUCONATE (UNII: R6Q3791S76) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) C13-15 ALKANE (UNII: 114P5I43UJ) WATER (UNII: 059QF0KO0R) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETYL ALCOHOL (UNII: 936JST6JCN) LAURYL LAURATE (UNII: GPW77G0937) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) ASTROCARYUM VULGARE KERNEL OIL (UNII: 1IQY04O559) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-613-01 30 mL 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 final M020 01/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 01/01/2023 Labeler - Supergoop, LLC (117061743) Registrant - Supergoop, LLC (117061743)
