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
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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
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INGREDIENTS AND APPEARANCE
G AND H PROTECT BODY
ensulizole, octisalate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10056-025 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 17 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 165.55 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:10056-025-00 1 in 1 CARTON 07/10/2023 1 100 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 Drug M020 07/10/2023 Labeler - Access Business Group LLC (839830713)