MINERAL SPF STARTER KIT- titanium dioxide, zinc oxide kit

Mineral SPF Starter Kit by

Drug Labeling and Warnings

Mineral SPF Starter Kit by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Mineral Sheerscreen SPF 30 Active Ingredients

Zinc Oxide 17.5% Sunscreen

Mineral Mattescreen SPF 40 Active Ingredient

Titanium Dioxide 1.3% Sunscreen

Zinc Oxide 17.4% Sunscreen

Play Mineral Lotion SPF 30 Active Ingredients

Zinc Oxide 16% Sunscreen

PURPOSE

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

For External use only

Do not use on damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove.

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

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

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 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 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

Keep out of reach of children. If product is swallowed, get medical help, or contact a poison control center right away.

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

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)

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

Supergoop!
100% Mineral SPF
Starter Kit
Protect sensitive skin with 100% mineral SPF favorites for face & body

INGREDIENTS AND APPEARANCE

MINERAL SPF STARTER KIT 
titanium dioxide, zinc oxide kit

Product 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 cream

Product 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 cream

Product 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 cream

Product 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)