PREP AND PRIME SPF MINI SET- avobenzone, homosalate, octisalate, octocrylene, zinc oxide kit

Prep and Prime SPF Mini Set by

Drug Labeling and Warnings

Prep and Prime SPF Mini Set by is a Otc medication manufactured, distributed, or labeled by TAYLOR JAMES, LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Mineral Sheerscreen SPF 30

Active ingredients Purpose

Zinc Oxide 17.5% Sunscreen

Superscreen Daily Moisturizer SPF 40

Active Ingredients Purpose

Avobenzone 2.5% Sunscreen

Homosalate 8% Sunscreen

Octisalate 5% Sunscreen

Glowscreen SPF 40

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Octisalate 5% Sunscreen

Octocrylene10% Sunscreen

Zincsreen 100% Mineral Lotion SPF 40

Active Ingredients Purpose

Zinc Oxide 13% Sunscreen

PURPOSE

Uses

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

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.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes

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 Measure​ 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 value of 15 or higher and other sun protection measures including:

• ​Limit time in the sun, especially from 10 a.m. - 2p.m.
• Wear Long-sleeved shirts, pants hats and sunglasses
• Children under 6 months ask a doctor

Mineral Sheerscreen Broad Spectrum Sunscreen SPF 30

Water, Isododecane, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Propanedlol, Glycerin, Squalane, Trioctyldodecyl Citrate, Polyglycerln-3, Polyglyceryl-3 Lactate/Laurate, Polysilicone-11, Cetearyl Alcohol, Glyceryl Stearate, Sodium Stearoyl Glutamate, Butylene Glycol, Xanthan Gum, Polyacrylate Crosspolymer-6, lsostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Caprylhydroxamic Acid, Citric Acid, Aloe Barbadensis Leaf Juice, Lespedeza Capitata Leaf/Stem Extract, Maltodextrin, Sodium Hyaluronate

Superscreen Daily Moisturizer Broad Spectrum SPF 40

Inactive ingredients Water, Cartamus Tinctorius (safflower) Olesomes, Glycerin, C12-15 Alkyl Benzoate, Polyester-7, Ammonium Acryloyldimethyldimethyltaurate/VP Copolymer, Neopentyl Glycol Diheptanoate, Carthamus Tinctorius (Safflower) Seedcake extract, Aphanizomenon Flos-Aquae Extract, Inulin Lauryl Carbamate, Xanthan Gum, Biosaccharide Gum-4, Cerium Oxide, Platinum Powder, 1,2-hexanediol, Ehtylhexylglycerin, Phenethyl Alcohol, Chlorphenesin

Zinc screen Broad Spectrum Sunscreen SPF 40

Inactive Ingredients

Water, Tetradecane, Cetearyl Nonanoate, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Isopropyl Myristate, Glycerin, Polyglyceryl-3 Diisostearate, Mica, Propanediol, Disteardimonium Hectorite, Gluconolactone, Polyglyceryl-6 Polyricinoleate, Brassica Campestris/Aleurites Fordi Oil Copolymer, Polyhydrostearic Acid, Sodium Chloride, Magnesium Sulfate, Fructose, Octyldodecyl Oleate, Tocopherol, Cocos Nucifera (Coconut) Fruit Extract, Sodium Benzoate, Iron oxides (CI 77492), Dodecane, Hexadecane, Titanium Dioxide (CI 77891), Withania Somnifera Flower Extract, Iron Oxides (CI 77491), Vaccinium Angustifolia (Blueberry) Fruit Extract, Silica, Calcium Gluconate

PRINCIPAL DISPLAY PANEL

Prep & Prime

SPF Mini Set

Give your skin daily hydration with this sample set of moisturizing SPFs and multitasking primers

Mineral Sheerscreen SPF 30 (10 ml)

Superscreen Daily Moisturizer SPF 40 (10 ml)

Glowscreen SPF 40 (10 ml)

Zincscreen 100% Mineral Lotion SPF 40 (10 ml)

Glow screen SPF 40

Inactive Ingredients
Water, Propanediol, Butyloctyl Salicylate, Glycerin, C12-15 Alkyl Benzoate, Polymethylsilsesquioxane, Niacinamide, Glyceryl Stearate Citrate, Bismuth Oxychloride, Mica, Titanium Dioxide, Lauryl Lactate, Isododecane, Isodecyl Neopentanoate, Glyceryl Stearate, Diisopropyl Sebacate, Cetyl Phosphate, Caprylic/Capric Triglyceride, Coco-Caprylate, Ethylhexyl Hydroxystearate, Butylene Glycol, Arginine, Hydroxyacetophenone, Caprylyl Glycol, 1,2-Hexanediol, Iron Oxides, Sodium Hyaluronate, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Trisodium Ethylenediamine Disuccinate, Phospholipids, Limonium Gerberi Extract, Leuconostoc/Radish Root Ferment Filtrate, Theobroma Cacao (Cocoa) Seed Extract, Pantothenic Acid, Tocopherol, Helianthus Annuus (sunflower) Seed Oil, Ferulic Acid

Prep & Prime SPF Mini Set

Prep & Prime

SPF Mini Set

Give your skin daily hydration with this sample set of moisturizing SPFs and multitasking primers

Mineral sheerscreen SPF 30 (10 ml)

Superscreen Daily Moisturizer SPF 40 (10 ml)

Glowscreen SPF 40 (10 ml)

Zincscreen 100% Mineral Lotion SPF 40 (10 ml)

Mineral Sheerscreen Broad Spectrum Sunscreen SPF 30

Mineral Sheerscreen SPF 30

SPF 30

100% Mineral

Broad Spectrum Sunscreen

SPF 30 PA+++

0.34 fl. oz. / 10 ml.

Superscreen Daily Moisturizer SPF 40

Superscreen Daily Moisturizer SPF 40

SPF 40

Broad Spectrum Sunscreen SPF 40 PA+++

0.34 fl. oz. / 10 ml

Glowscreen SPF 40

Glowscreen SPF 40

Broad Spectrum Sunscreen

SPF 40 PA+++

0.34 fl. oz. / 10 ml

Zincscreen 100% Mineral Lotion SPF 40

Zincscreen 100% Mineral Lotion

SPF 40

Broad Spectrum Sunscreen SPF 40 PA+++

0.34 fl.oz. / 10ml

INGREDIENTS AND APPEARANCE

PREP AND PRIME SPF MINI SET 
avobenzone, homosalate, octisalate, octocrylene, zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-405

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-405-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	09/27/2021

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	10 mL
Part 2	1 TUBE	10 mL
Part 3	1 BOTTLE	10 mL
Part 4	1 BOTTLE	10 mL

Part 1 of 4

MINERAL SHEERSCREEN SPF 30 
zinc oxide lotion

Product Information
Item Code (Source)	NDC: 75936-407
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
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
XANTHAN GUM (UNII: TTV12P4NEE)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)
ISOSTEARIC ACID (UNII: X33R8U0062)
WATER (UNII: 059QF0KO0R)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SQUALANE (UNII: GW89575KF9)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISODODECANE (UNII: A8289P68Y2)
PROPANEDIOL (UNII: 5965N8W85T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-407-01	10 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/27/2021

Part 2 of 4

SUPERSCREEN DAILY MOISTURIZER SPF 40 
avobenzone, homosalate, octisalate cream

Product Information
Item Code (Source)	NDC: 75936-406
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARTHAMUS TINCTORIUS SEEDCAKE (UNII: DHQ13F4N2W)
CERIC OXIDE (UNII: 619G5K328Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
WATER (UNII: 059QF0KO0R)
POLYESTER-7 (UNII: 0841698D2F)
APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
PLATINUM (UNII: 49DFR088MY)
CHLORPHENESIN (UNII: I670DAL4SZ)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-406-01	10 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/27/2021

Part 3 of 4

GLOWSCREEN SPF 40 
avobenzone, octisalate, octocrylene cream

Product Information
Item Code (Source)	NDC: 75936-408
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CHLORPHENESIN (UNII: I670DAL4SZ)
ARGININE (UNII: 94ZLA3W45F)
CETYL PHOSPHATE (UNII: VT07D6X67O)
COCO-CAPRYLATE (UNII: 4828G836N6)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
TOCOPHEROL (UNII: R0ZB2556P8)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
NIACINAMIDE (UNII: 25X51I8RD4)
MICA (UNII: V8A1AW0880)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
SUNFLOWER OIL (UNII: 3W1JG795YI)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
LAURYL LACTATE (UNII: G5SU0BFK7O)
ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
COCOA (UNII: D9108TZ9KG)
FERULIC ACID (UNII: AVM951ZWST)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
ISODODECANE (UNII: A8289P68Y2)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
LIMONIUM GERBERI WHOLE (UNII: 2J5K7YCF9F)
PANTOTHENIC ACID (UNII: 19F5HK2737)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-408-01	10 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/27/2021

Part 4 of 4

ZINCSCREEN 100 MINERAL SPF 40 
zinc oxide lotion

Product Information
Item Code (Source)	NDC: 75936-409
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CETEARYL NONANOATE (UNII: F6ZWV2F361)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
FRUCTOSE (UNII: 6YSS42VSEV)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
DODECANE (UNII: 11A386X1QH)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
MICA (UNII: V8A1AW0880)
PROPANEDIOL (UNII: 5965N8W85T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HEXADECANE (UNII: F8Z00SHP6Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCONUT (UNII: 3RT3536DHY)
WATER (UNII: 059QF0KO0R)
TETRADECANE (UNII: 03LY784Y58)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-409-01	10 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/27/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/27/2021

Labeler - TAYLOR JAMES, LTD (033381850)