PREP AND PRIME SPF MINI SET- avobenzone, homosalate, octisalate, octocrylene, zinc oxide 
TAYLOR JAMES, LTD

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.

----------

Prep and Prime SPF Mini Set

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

Uses

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

Directions

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:

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

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)

prep prime mini set front

prep prime SPF mini set back

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.

mineral Sheerscreen SPF 30

Superscreen Daily Moisturizer SPF 40

Superscreen Daily Moisturizer SPF 40

SPF 40

Broad Spectrum Sunscreen SPF 40 PA+++

0.34 fl. oz. / 10 ml

Superscreen Daily Moisturizer SPF 40

Glowscreen SPF 40

Glowscreen SPF 40

Broad Spectrum Sunscreen

SPF 40 PA+++

0.34 fl. oz. / 10 ml

Glowscreen SPF 40

Zincscreen 100% Mineral Lotion SPF 40

Zincscreen 100% Mineral Lotion

SPF 40

Broad Spectrum Sunscreen SPF 40 PA+++

0.34 fl.oz. / 10ml

zincscreen 100% Mineral lotion SPF 40

PREP AND PRIME SPF MINI SET 
avobenzone, homosalate, octisalate, octocrylene, zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-405
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-405-011 in 1 KIT; Type 1: Convenience Kit of Co-Package09/27/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 10 mL
Part 21 TUBE 10 mL
Part 31 BOTTLE 10 mL
Part 41 BOTTLE 10 mL
Part 1 of 4
MINERAL SHEERSCREEN SPF 30 
zinc oxide lotion
Product Information
Item Code (Source)NDC:75936-407
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-407-0110 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/27/2021
Part 2 of 4
SUPERSCREEN DAILY MOISTURIZER SPF 40 
avobenzone, homosalate, octisalate cream
Product Information
Item Code (Source)NDC:75936-406
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-406-0110 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/27/2021
Part 3 of 4
GLOWSCREEN SPF 40 
avobenzone, octisalate, octocrylene cream
Product Information
Item Code (Source)NDC:75936-408
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-408-0110 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/27/2021
Part 4 of 4
ZINCSCREEN 100 MINERAL SPF 40 
zinc oxide lotion
Product Information
Item Code (Source)NDC:75936-409
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-409-0110 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/27/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/27/2021
Labeler - TAYLOR JAMES, LTD (033381850)

Revised: 11/2021
Document Id: d0efa427-e9ba-2d58-e053-2a95a90a6f56
Set id: cc715fe5-2c2a-f69a-e053-2995a90ab57d
Version: 2
Effective Time: 20211116
 
TAYLOR JAMES, LTD