Label: EVERYDAY SUPERSTARS SPF DISCOVERY KIT- avobenzone, homosalate, octisalate, octocrylene, zinc oxide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 82384-0034-1, 82384-0035-1, 82384-0036-1, 82384-0037-1 - Packager: System Beauty, 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 December 16, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Unseen Sunscreen Active Ingredients
- Mineral Sheerscreen SPF 30 Active ingredients
- Play Everyday Sunscreen SPF 50 with Sunflower Extract Active ingredient
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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Unseen sunscreen SPF 40
Directions
- apply generously and evenly 15 minutes before sun exposure
- reapply:
after 40 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
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Mineral Sheerscreen SPF 30 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 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 sunglassess
- Children under 6 months: Ask a doctor.
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Play Everyday Sunscreen SPF 50 with Sunflower Extract directions
Directions
- Apply liberally 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 broad spectrum SPF 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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Unseen Sunscreen SPF 40 Inactive ingredients
Inactive Ingredients
Isododecane, Dimethicone Crosspolymer, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Polymethylsilsesquioxane, Isohexadecane, Dicrapylyl Carbonate, Meadowfoam Estolide, Caprylic/Capric Triglyceride, Polyester-7, Neopentyl Glycol Diheptanoate, Lithothamnion Calcareum Extract,Butyrospermum Parkii (Shea) Butter, Jojoba Esters, Mannitol, Boswellia Serrata Resin Extract, Lecithin, Microcrystalline Cellulose, Diatomaceous Earth, Zinc Sulfate, Silica, Tocopherol
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Mineral Sheerscreen Inactive ingredients
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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Play Everyday Lotion SPF 50 with Sunflower Extract Inactive ingredients
Water, Acrylates Copolymer, Diisopropyl Sebacate, Glycerin, Isodecyl Neopentanoate, Isododecane, Lauryl Lactate, Cetyl Alcohol, Potassium Cetyl Phosphate, Brassica Camprestris/Aleurites Fordi Copolymer, Oryza Sativa (Rice) Bran Extract, Cetearyl Olivate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone, Sorbitan Olivate, Diethylhexyl Syringylidenemalonate, Aniba Rosaeodora (Rosewood) Wood Oil, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Ocimum Bascilicum (Basil) Flower/Leaf Extract, Pelargonium Graveolens Flower Oil, Pogostemon Cablin Oil, Pentylene Glycol, 1,2-hexanediol, Caprylyl Glycol, Xanthan Gum, Helianthus Annuus (Sunflower) Extract, Behenic Acid, Cetyl Behenate, Isostearyl Isostearate, Trisodium Ethylenediamene Disuccinate, Tocopherol, Allantoin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Caprylic/Capric Triglyceride,Panthenol, Pentasodium Triphosphate, Citric Acid
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EVERYDAY SUPERSTARS SPF DISCOVERY KIT
avobenzone, homosalate, octisalate, octocrylene, zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82384-0034 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82384-0034-1 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 12/17/2021 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 UNSEEN SUNSCREEN SPF 40
avobenzone, homosalate, octisalate, octocrylene creamProduct Information Item Code (Source) NDC:82384-0035 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 8 g in 100 mL Inactive Ingredients Ingredient Name Strength LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) SHEA BUTTER (UNII: K49155WL9Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK) ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB) DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85) TOCOPHEROL (UNII: R0ZB2556P8) MANNITOL (UNII: 3OWL53L36A) DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF) POLYESTER-7 (UNII: 0841698D2F) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ISODODECANE (UNII: A8289P68Y2) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) ISOHEXADECANE (UNII: 918X1OUF1E) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) CAPRYLYL GLYCOL (UNII: 00YIU5438U) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82384-0035-1 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 part352 12/17/2021 Part 2 of 3 MINERAL SHEERSCREEN SPF 30
zinc oxide creamProduct Information Item Code (Source) NDC:82384-0036 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 DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ISODODECANE (UNII: A8289P68Y2) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALOE VERA LEAF (UNII: ZY81Z83H0X) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) GLYCERIN (UNII: PDC6A3C0OX) SQUALANE (UNII: GW89575KF9) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) LESPEDEZA CAPITATA FLOWERING TOP (UNII: F930LFZ4LF) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MALTODEXTRIN (UNII: 7CVR7L4A2D) WATER (UNII: 059QF0KO0R) PROPANEDIOL (UNII: 5965N8W85T) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) XANTHAN GUM (UNII: TTV12P4NEE) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82384-0036-1 15 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 12/17/2021 Part 3 of 3 PLAY EVERYDAY SPF 50 WITH SUNFLOWER EXTRACT
avobenzone, homosalate,octisalate, octocrylene lotionProduct Information Item Code (Source) NDC:82384-0037 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 HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.5 g in 100 mL Inactive Ingredients Ingredient Name Strength CETEARYL OLIVATE (UNII: 58B69Q84JO) LAURYL LACTATE (UNII: G5SU0BFK7O) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) CAPRYLYL GLYCOL (UNII: 00YIU5438U) LEMON OIL, COLD PRESSED (UNII: I9GRO824LL) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) ROSEWOOD OIL (UNII: F2522O5L7B) ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B) POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) TOCOPHEROL (UNII: R0ZB2556P8) ALLANTOIN (UNII: 344S277G0Z) ROSEMARY (UNII: IJ67X351P9) WATER (UNII: 059QF0KO0R) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) SORBITAN OLIVATE (UNII: MDL271E3GR) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) BEHENIC ACID (UNII: H390488X0A) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PENTYLENE GLYCOL (UNII: 50C1307PZG) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) ISODODECANE (UNII: A8289P68Y2) CETYL ALCOHOL (UNII: 936JST6JCN) RICE BRAN (UNII: R60QEP13IC) XANTHAN GUM (UNII: TTV12P4NEE) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) CETYL BEHENATE (UNII: WFM51TRO3E) CHLORPHENESIN (UNII: I670DAL4SZ) EUCALYPTUS OIL (UNII: 2R04ONI662) OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) PANTHENOL (UNII: WV9CM0O67Z) SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82384-0037-1 30 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 12/17/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/17/2021 Labeler - System Beauty, LLC (809198398)
