Label: GRAY MALIN KIT- avobenzone, homosalate, octisalate, octocrylene kit

  • Category: HUMAN OTC DRUG LABEL

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

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  • 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

  • PURPOSE

    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

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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    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

    • Apply generously and evenly 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
  • DOSAGE & ADMINISTRATION

    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 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
  • 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

  • Antioxidant body mist SPF 50 Vitamin C

    Inactive Ingredients

    Alcohol Denat., Butyloctyl Salicylate, Camellia Sinensis Leaf Extract, Cananga Odorata Flower Oil, Caprylic/Capric Triglyceride, Citrus Grandis (Grapfruit) Peel Oil, Citrus medica Limonium (Lemon) Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Citrus reticulata (Tangerine) Leaf Oil, Citrus Sinensis peel Oil, Dicaprylyl Carbonate, Diisopropyl adiipate, Ethyl Ferulate, Euterpe Oleracea Fruit Extract, Helianthuus Annuus (Sunflower) Seed Oil, Isodecyl Neopentanoate, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Mentha Viridis(Spearmint) Tetrahexyldecyl Ascorbate, Tridecyl Neopentanoate, VA/Butyl Maleate/ Isobornyl Acrylate Copolymer, Vitis Vinifera (Grape) Seed Oil

  • Glow Oil SPF 50

    Inactive Ingredients

    Caprylic/Capric Triglyceride, Alcohol, Octyldodecanol, C12-15 Alkyl Benzoate, Polyester-8, Polyamide-3, Lauryl Lactate, Isodecyl Neopentanoate, Diisopropyl Sebacate, Diethylhexylsyringylidenemalonate, Tocopherol, Glycine Soja (Soybean)Oil, Vitis Vinifera (grape) Seed Oil, Raphanus Sativus (Radish) Seed Oil, Limnanthes Alba(Meadowfoam) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (coconut) Oil, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, Pentaerythrityl Tetra-di-t-butyl hydroxyhydrocinnamate. Alaria Esculanta Extract, t-Butyl Alcohol, Cucumis Sativus(cucumber) Fruit Extract, Denatonium Benzoate, Citric Acid

  • Lip Shield SPF 30 with mint

    Supergoop!

    x GRAYMALIN

    PLAY SPF 30

    Lip Shield

    With Mint

    Broad Spectrum Sunscreen SPF 30

    Water & Sweat Resistant (80 minutes)

    0.15 oz./ 4.25 g

    lip shield mint

  • Antioxidant Body Mist With vitamin C SPF 30

    Supergoop!

    x GRAYMALIN SPF 50

    Antioxidant Body Mist

    With vitamin C

    Broad Spectrum Sunscreen SPF 30

    Water & Sweat Resistant (80 minutes)

    3 fl. oz./ 89 ml

    mist SPF 50

  • Glow Oil SPF 50

    Supergoop!

    x GRAYMALIN

    Glow Oil

    Broad Spectrum Sunscreen SPF 50

    Water & Sweat Resistant (80 minutes)

    1 fl oz / 30 ml

    glow oil bottle

    glow oil back

  • Unseen Sunscreen SPF 40

    Supergoop!

    Unseen Sunscreen

    Broad Spectrum Sunscreen SPF 40 PA ++++

    Water & Sweat Resistant (40 minutes)

    0.5 fl. oz. / 15 ml

    unseen SPF 40 tube

    unseen sunscreen SPF 40 back

  • Defense Refresh (Re) Setting Mist SPF 40

    Supergoop!

    x GRAYMALIN

    Defense Refresh

    (Re) Setting Mist

    Broad Spectrum Sunscreen SPF 40

    Water & Sweat Resistant (40 minutes)

    1.0 fl. oz. / 30 ml

    Defense Refresh SPF 40

    defense refresh back

  • Everyday Lotion with Sunflower Extract

    Supergoop!

    PLAY

    SPF 50

    Everyday Lotion

    with Sunflower Extract

    Broad Spectrum Sunscreen SPF 50 PA++++

    Water & Sweat Resistant (80 minutes)

    2.4 fl. oz. / 71 ml.

    play everyday lotion tube

  • INGREDIENTS AND APPEARANCE
    GRAY MALIN KIT 
    avobenzone, homosalate, octisalate, octocrylene kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-244
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-244-011 in 1 KIT; Type 1: Convenience Kit of Co-Package03/20/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 15 mL
    Part 21 BOTTLE, SPRAY 15 mL
    Part 32 TUBE 71 mL
    Part 41 BOTTLE 30 mL
    Part 51 BOTTLE 89 mL
    Part 61 CYLINDER 4.25 g
    Part 1 of 6
    UNSEEN SUNSCREEN SPF 40 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Item Code (Source)NDC:75936-245
    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:75936-245-0115 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 6
    DEFENSE REFRESH (RE)SETTING MIST SPF 40 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Item Code (Source)NDC:75936-246
    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:75936-246-0130 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 6
    PLAY EVERYDAY SPF 50 WITH SUNFLOWER EXTRACT 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Item Code (Source)NDC:75936-247
    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
    ISODODECANE (UNII: A8289P68Y2)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    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)  
    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:75936-247-0130 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
    Part 4 of 6
    GLOW OIL SUNSCREEN SPF 50 
    avobenzone, homosalate, octisalate, octocrylene oil
    Product Information
    Item Code (Source)NDC:75936-248
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 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
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    ALARIA ESCULENTA (UNII: EJ9JK8J58D)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-248-0130 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 finalpart35204/08/2021
    Part 5 of 6
    PLAY ANTIOXIDANT BODY MIST SPF 50 WITH VITAMIN C 
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Item Code (Source)NDC:75936-249
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9.8 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9.5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ORANGE OIL TERPENELESS (UNII: L8B7EWV9I7)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CANANGA OIL (UNII: 8YOY78GNNX)  
    LIME OIL (UNII: UZH29XGA8G)  
    CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
    CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ACAI (UNII: 46AM2VJ0AW)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)  
    MANDARIN OIL (UNII: NJO720F72R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-249-0189 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 finalpart35204/14/2021
    Part 6 of 6
    PLAY LIP SHIELD WITH MINT BROAD SPECTRUM SPF 30 
    avobenzone, homosalate, octisalate, octocrylene stick
    Product Information
    Item Code (Source)NDC:75936-253
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CERESIN (UNII: Q1LS2UJO3A)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    JOJOBA OIL (UNII: 724GKU717M)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-253-014.25 g in 1 CYLINDER; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/26/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/20/2021
    Labeler - TAYLOR JAMES, LTD. (033381850)