Label: HEAD-TO-TOE FAVORITES MINI SET- avobenzone, homosalate, octisalate, octocrylene kit
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Contains inactivated NDC Code(s)
NDC Code(s): 82384-0025-1, 82384-0026-1, 82384-0027-1, 82384-0028-1, view more82384-0029-1 - 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 9, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Play Everyday Sunscreen SPF 50 with sunflower extract
- Unseen Sunscreen Broad Spectrum SPF 40
- Glow Screen Body Broad Spectrum SPF 40
- Glowscreen 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 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 10a.m. – 2p.m.Wear long-sleeved shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor
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Glow screen body Broad Spectrum SPF 40
- 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 decreases this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection meausres 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
- 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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Play Everyday Sunscreen SPF 50 with sunflower extract
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
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Unseen sunscreen SPF 40
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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Glow Screen Body Broad Spectrum SPF 40
Aletris Farinosa Root Extract, Bisabolol, Butyloctyl Salicylate,Calcium Sodium Borosilicate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryly Glycol, Cetearyl Alcohol, Coco-Caprylate/Caprate, Coco-Glucoside, Coconut Alkanes, Erythritol, Ethyl Ferulate, Ethylhexyl Methoxycrylene, Glycerin, Glyceryl Stearate, Hydrogenated Polycyclopentadiene, Methyl Dlhydroabietate, Mica, Polyester-8, Propanedlol, Sodium Gluconate, Sodium Polyacrylate Starch, Sodium Stearoyl Glutamate, Titanium Dioxide, Tocopherol, Water, Xanthan Gum
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Glowscreen SPF 40
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
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Head to Toe SPF Favorities Mini Set
Head to Toe SPF Favorities Mini Set
Protect your skin from head to toe with this sample set, featuring our favorite glowy and everyday SPFs for face & body.
Unseen Sunscreen SPF 40 (10 ml)
Glowscreen SPF 40 (10ml)
Play Everyday Lotion SPF 50 with sunflower Extract (10ml)
Glowscreen Body SPF 40 (10 ml)
- Play Everyday Lotion SPF 50
- Unseen Sunscreen SPF 40
- Glowscreen Body SPF 40
- Glowscreen SPF 40
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INGREDIENTS AND APPEARANCE
HEAD-TO-TOE FAVORITES MINI SET
avobenzone, homosalate, octisalate, octocrylene kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82384-0025 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82384-0025-1 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 TUBE 10 mL Part 4 1 TUBE 10 mL Part 1 of 4 PLAY EVERYDAY SPF 50 WITH SUNFLOWER EXTRACT
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Item Code (Source) NDC:82384-0026 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength LAURYL LACTATE (UNII: G5SU0BFK7O) SORBITAN OLIVATE (UNII: MDL271E3GR) ROSEWOOD OIL (UNII: F2522O5L7B) ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B) CHLORPHENESIN (UNII: I670DAL4SZ) BEHENIC ACID (UNII: H390488X0A) PANTHENOL (UNII: WV9CM0O67Z) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ROSEMARY (UNII: IJ67X351P9) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ) PENTYLENE GLYCOL (UNII: 50C1307PZG) LEMON OIL, COLD PRESSED (UNII: I9GRO824LL) OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EUCALYPTUS OIL (UNII: 2R04ONI662) POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO) RICE BRAN (UNII: R60QEP13IC) CETYL ALCOHOL (UNII: 936JST6JCN) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) CETEARYL OLIVATE (UNII: 58B69Q84JO) GLYCERIN (UNII: PDC6A3C0OX) ISODODECANE (UNII: A8289P68Y2) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) TOCOPHEROL (UNII: R0ZB2556P8) ALLANTOIN (UNII: 344S277G0Z) CAPRYLYL GLYCOL (UNII: 00YIU5438U) XANTHAN GUM (UNII: TTV12P4NEE) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y) CETYL BEHENATE (UNII: WFM51TRO3E) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82384-0026-1 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 GLOWSCREEN BODY SPF 40
avobenzone, homosalate, octisalate, octocrylene creamProduct Information Item Code (Source) NDC:82384-0029 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength PROPANEDIOL (UNII: 5965N8W85T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) COCONUT ALKANES (UNII: 1E5KJY107T) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) ERYTHRITOL (UNII: RA96B954X6) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) SODIUM GLUCONATE (UNII: R6Q3791S76) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ETHYL FERULATE (UNII: 5B8915UELW) GLYCERIN (UNII: PDC6A3C0OX) XANTHAN GUM (UNII: TTV12P4NEE) COCO GLUCOSIDE (UNII: ICS790225B) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) MICA (UNII: V8A1AW0880) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) ALETRIS FARINOSA ROOT (UNII: O021JGR97X) LEVOMENOL (UNII: 24WE03BX2T) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82384-0029-1 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 UNSEEN SUNSCREEN SPF 40
avobenzone, homosalate, octisalate, octocrylene creamProduct Information Item Code (Source) NDC:82384-0027 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 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 4 g in 100 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL GLYCOL (UNII: 00YIU5438U) SHEA BUTTER (UNII: K49155WL9Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TOCOPHEROL (UNII: R0ZB2556P8) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85) MANNITOL (UNII: 3OWL53L36A) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) POLYESTER-7 (UNII: 0841698D2F) DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) ZINC SULFATE (UNII: 89DS0H96TB) ISODODECANE (UNII: A8289P68Y2) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) ISOHEXADECANE (UNII: 918X1OUF1E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82384-0027-1 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 4 of 4 GLOWSCREEN SPF 40
avobenzone, octisalate, octocrylene creamProduct Information Item Code (Source) NDC:82384-0028 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 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 Inactive Ingredients Ingredient Name Strength LAURYL LACTATE (UNII: G5SU0BFK7O) CETYL PHOSPHATE (UNII: VT07D6X67O) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) SUNFLOWER OIL (UNII: 3W1JG795YI) COCO-CAPRYLATE (UNII: 4828G836N6) FERRIC OXIDE RED (UNII: 1K09F3G675) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) PANTOTHENIC ACID (UNII: 19F5HK2737) PROPANEDIOL (UNII: 5965N8W85T) NIACINAMIDE (UNII: 25X51I8RD4) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) MICA (UNII: V8A1AW0880) ISODODECANE (UNII: A8289P68Y2) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E) CAPRYLYL GLYCOL (UNII: 00YIU5438U) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) LIMONIUM GERBERI WHOLE (UNII: 2J5K7YCF9F) COCOA (UNII: D9108TZ9KG) FERULIC ACID (UNII: AVM951ZWST) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ARGININE (UNII: 94ZLA3W45F) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) TOCOPHEROL (UNII: R0ZB2556P8) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82384-0028-1 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/27/2021 Labeler - System Beauty, LLC (809198398)