HEAD TO TOE KIT- avobenzone, homosalate, octisalate, octocrylene 
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.

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Head-to-Toe Kit

Play Everyday Sunscreen SPF 50 with Sunflower extract Active ingredients

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 7.5% Sunscreen

Defense Refresh (Re)setting Mist SPF 40

ACTIVE INGREDIENT PURPOSE

Avobenzone 2.8%..............Sunscreen

Homosalate 9.8%.............Sunscreen

Octisalate 4.9%..................Sunscreen

Octocrylene 9.5%...............Sunscreen

Unseen Sunscreen SPF 40 active ingredients

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 8% Sunscreen

Octocrylene 4% Sunscreen

Octisalate 5% Sunscreen

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. If 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. Rinse with water to remove

Play Everyday Lotion SPF 50 with Sunflower Extract Directions

Directions

immediately after towel drying
at least every 2 hours

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:

Directions

immediately after towel drying
at least every 2 hours

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:

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

Defense Refresh (Re)setting Mist SPF 40 Inactive Ingredients

Inactive Ingredients

Alcohol Denat., Bisabolol, Brassica Campestris/Aleurites Fordi Oil Copolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Dicaprylyl Carbonate, Diethylhexyl Syringylidenemalonate, Diheptyl Succinate, Diisooctyl Succinate, Ethyl Ferulate, Isododecane, Lauroyl Lysine, Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Nylon-12, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate

Play Everyday Sunscreen SPF 50 with sunflower Inactive ingredients

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

Supergoop!

SPF FROM HEAD TO TOE

Three SPF essentials for happy, hydrated, and protected skin

Unseen Sunscreen SPF 40

0.5 fl.oz./ 15 ml

Defense Refresh (Re)setting Mist SPF 40

1 fl. oz. / 30 ml

Play Everyday Lotion SPF 50 with Sunflower Extract

1 fl. oz. / 30 ml

Head to Toe

HEAD TO TOE KIT 
avobenzone, homosalate, octisalate, octocrylene kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-240
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-240-011 in 1 KIT; Type 1: Convenience Kit of Co-Package03/20/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 10 TUBE 1 mL
Part 20 BOTTLE, SPRAY 1 mL
Part 30 TUBE 1 mL
Part 1 of 3
UNSEEN SUNSCREEN SPF 40 
avobenzone, homosalate, octisalate, octocrylene cream
Product Information
Item Code (Source)NDC:75936-242
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ISODODECANE (UNII: A8289P68Y2)  
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
ZINC SULFATE (UNII: 89DS0H96TB)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SHEA BUTTER (UNII: K49155WL9Y)  
MANNITOL (UNII: 3OWL53L36A)  
POLYESTER-7 (UNII: 0841698D2F)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-242-0115 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 finalpart35203/20/2021
Part 2 of 3
DEFENSE REFRESH (RE)SETTING MIST SPF 40 
avobenzone, homosalate, octisalate, octocrylene cream
Product Information
Item Code (Source)NDC:75936-243
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.8 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9.8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
ISODODECANE (UNII: A8289P68Y2)  
SPEARMINT OIL (UNII: C3M81465G5)  
LEVOMENOL (UNII: 24WE03BX2T)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
LAUROYL LYSINE (UNII: 113171Q70B)  
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
ALCOHOL (UNII: 3K9958V90M)  
ETHYL FERULATE (UNII: 5B8915UELW)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
NYLON-12 (UNII: 446U8J075B)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-243-0130 mL in 1 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/20/2021
Part 3 of 3
PLAY EVERYDAY SPF 50 WITH SUNFLOWER EXTRACT 
avobenzone, homosalate, octisalate, octocrylene cream
Product Information
Item Code (Source)NDC:75936-241
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ALLANTOIN (UNII: 344S277G0Z)  
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
BEHENIC ACID (UNII: H390488X0A)  
CETYL BEHENATE (UNII: WFM51TRO3E)  
RICE BRAN (UNII: R60QEP13IC)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
ROSEWOOD OIL (UNII: F2522O5L7B)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
ROSEMARY (UNII: IJ67X351P9)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
ISODODECANE (UNII: A8289P68Y2)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
PANTHENOL (UNII: WV9CM0O67Z)  
LAURYL LACTATE (UNII: G5SU0BFK7O)  
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-241-0130 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 finalpart35203/20/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/20/2021
Labeler - TAYLOR JAMES, LTD. (033381850)

Revised: 11/2021
Document Id: d0ef6a43-2dfc-8eac-e053-2a95a90a7c42
Set id: c0918caf-ea55-ca2b-e053-2995a90a4c03
Version: 2
Effective Time: 20211116
 
TAYLOR JAMES, LTD.