Label: PREP AND PRIME SPF MINI SET- avobenzone, homosalate, octisalate, octocrylene, zinc oxide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-405-01, 75936-406-01, 75936-407-01, 75936-408-01, view more75936-409-01 - Packager: TAYLOR JAMES, LTD
- 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 November 16, 2021
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
- Superscreen Daily Moisturizer SPF 40
- Glowscreen SPF 40
- Zincsreen 100% Mineral Lotion SPF 40
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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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
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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
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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
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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
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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
- Mineral Sheerscreen Broad Spectrum Sunscreen SPF 30
- Superscreen Daily Moisturizer SPF 40
- Glowscreen SPF 40
- Zincscreen 100% Mineral Lotion SPF 40
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INGREDIENTS AND APPEARANCE
PREP AND PRIME SPF MINI SET
avobenzone, homosalate, octisalate, octocrylene, zinc oxide kitProduct 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 lotionProduct 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 creamProduct 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 creamProduct 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 lotionProduct 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)
