G&h Protect Body Lotion

G&h Protect Body Lotion
SPL v4
SPL
SPL Set ID 03768ff4-0c67-48b3-a2f3-321d0a6790e8
Route
TOPICAL
Published
Effective Date 2022-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ensulizole (17 mg) Octisalate (50 mg) Zinc Cation (165.55 mg)
Inactive Ingredients
Water Propylheptyl Caprylate Propanediol Hexyl Laurate Caprylyl Trisiloxane Diphenylsiloxy Phenyl Trimethicone Ethylhexyl Palmitate Alcohol Tromethamine 1,2-hexanediol Stearalkonium Hectorite Triethoxycaprylylsilane Magnesium Sulfate, Unspecified Form Butylene Glycol Chlorella Vulgaris Disteardimonium Hectorite Anhydrous Dextrose Fructose Medium-chain Triglycerides Lauric Acid Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Isopropyl Myristate Isostearic Acid Xanthan Gum Tocopherol Glechoma Hederacea Whole Green Tea Leaf Ethylhexylglycerin Alcea Rosea Flower Rosemary Centella Asiatica Triterpenoids Limonene, (+)- Linalool, (+/-)- Geraniol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-10

Description

Ensulizole 1.700% Octisalate 5.000% Zinc Oxide 16.555%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Ensulizole 1.700% Octisalate 5.000% Zinc Oxide 16.555%

Uses
  • Helps prevent sunburn
Warnings

For external use only

Question?

USA: 1-800-253-6500

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
Do Not Use

on broken or damaged skin

Drug Facts

Other Information

Protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients

Ensulizole 1.700%

Octisalate 5.000%

Zinc Oxide 16.555%

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

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


Structured Label Content

Uses
  • Helps prevent sunburn
Purpose

Sunscreen

Warnings

For external use only

Question?

USA: 1-800-253-6500

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
Do Not Use (Do not use)

on broken or damaged skin

Drug Facts

Other Information (Other information)

Protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients (Active ingredients)

Ensulizole 1.700%

Octisalate 5.000%

Zinc Oxide 16.555%

Inactive Ingredients (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

When Using This Product (When using this product)

kep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if irritation or rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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