G AND H PROTECT BODY- ensulizole, octisalate, zinc oxide lotion 
Access Business Group LLC

----------

g&h Protect Body Lotion

Drug Facts

Active ingredients

Ensulizole 1.700%

Octisalate 5.000%

Zinc Oxide 16.555%

Purpose

Sunscreen

Uses

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

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

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)

Revised: 10/2023
Document Id: 085bcc1d-8ef6-1348-e063-6394a90af6cf
Set id: 03768ff4-0c67-48b3-a2f3-321d0a6790e8
Version: 4
Effective Time: 20231023
 
Access Business Group LLC