Label: G AND H PROTECT BODY- ensulizole, octisalate, zinc oxide lotion

  • NDC Code(s): 10056-025-00
  • Packager: Access Business Group LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients

    Ensulizole 1.700%

    Octisalate 5.000%

    Zinc Oxide 16.555%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • Warnings

    For external use only

    Do not use

    on broken or damaged skin

    When using this product

    kep out of eyes. Rinse with water to remove

    Stop use and ask a doctor

    if irritation or rash occurs

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Use a water-resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours 
    • Children under 6 months: ask a doctor
  • Other information

    Protect this product from excessive heat and direct sun

  • Inactive ingredients

    Water, Propylheptyl Caprylate, Propanediol, Hexyl Laurate, Acrylates Copolymer, Caprylyl Methicone, Diphenylsiloxy Phenyl Trimethicone, Ethylhexyl Palmitate, Alcohol Denat., Polyglyceryl-4, Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Tromethamine, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, 1,2-Hexanediol, Stearalkonium Hectorite, Triethoxycaprylylsilane, Poly C10-30 Alkyl Acrylate, Fragrance/Parfum, Magnesium Sulfate, Butylene Glycol, Chlorella Vulgaris Extract, Disteardimonium Hectorite, Glucose, Polyhydorxystearic Acid, Fructose, Caprylic/Capric Triglyceride, Fructooligosaccharides, Lauric Acid, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Isopropyl Myristate, Isostearic Acid, Lecithin, Xanthan Gum, Polyglyceryl-3 Polyricinoleate, Cynanchum Atratum Extract, Tocopherol, Glechoma Hederacea Extract, Buddleja Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Ethylhexylglycerin, Althaea Rosea Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Centella Asiatica Extract, Limonene, Linalool, Geraniol

  • Question?

    USA: 1-800-253-6500

  • Package Labeling:

    Label0

  • INGREDIENTS AND APPEARANCE
    G AND H PROTECT BODY 
    ensulizole, octisalate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10056-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE17 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION165.55 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ALCOHOL (UNII: 3K9958V90M)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GLECHOMA HEDERACEA WHOLE (UNII: L6O7WQK912)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALCEA ROSEA FLOWER (UNII: 1250O8MKPZ)  
    ROSEMARY (UNII: IJ67X351P9)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GERANIOL (UNII: L837108USY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10056-025-001 in 1 CARTON07/10/2023
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/10/2023
    Labeler - Access Business Group LLC (839830713)