SPL v1
SPL
SPL Set ID 686d0611-18e8-4905-a42b-4887127a5091
Route
TOPICAL
Published
Effective Date 2017-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (0.97 g) Titanium Dioxide (0.78 g) Octisalate (0.65 g) Zinc Cation (0.25 g)
Inactive Ingredients
Water Phenyl Trimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-08-01

Description

Active ingredients: Ethylhexyl Methoxycinnamate 7.50%, Titanium Dioxide 6.05%, Ethylhexyl Salicylate 5.00%, Zinc Oxide 1.96%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses: - Helps prevent sunburn. - If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Directions: Gently press the pull on the air cushion and pat it onto your skin

Warnings

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children.

Active Ingredient

Active ingredients: Ethylhexyl Methoxycinnamate 7.50%, Titanium Dioxide 6.05%, Ethylhexyl Salicylate 5.00%, Zinc Oxide 1.96%

Inactive Ingredient

Inactive ingredients: Water, Cyclopentasiloxane, Phenyl Trimethicone, Cyclohexasiloxane, Butylene Glycol, Glycerin, Niacinamide, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone,PEG-10 Dimethicone, Aluminum Hydroxide, Magnesium Sulfate, Stearic Acid, Disteardimonium Hectorite, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Polyhydroxystearic Acid , Caprylyl Glycol, Methyl Methacrylate Crosspolymer, Allantoin, Tocopheryl Acetate, Lecithin, Ethylhexyl Palmitate, Isostearic Acid, Isopropyl Myristate, Iron Oxides (CI 77491), Caprylhydroxamic Acid, Triethoxycaprylylsilane, Adenosine, Polyglyceryl-3 Polyricinoleate, Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Biosaccharide Gum-1, Sophora Japonica Fruit Extract, Pancratium Maritimum Extract, Fragrance

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children.

Description (DESCRIPTION)

Uses: - Helps prevent sunburn. - If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Directions: Gently press the pull on the air cushion and pat it onto your skin

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Ethylhexyl Methoxycinnamate 7.50%, Titanium Dioxide 6.05%, Ethylhexyl Salicylate 5.00%, Zinc Oxide 1.96%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water, Cyclopentasiloxane, Phenyl Trimethicone, Cyclohexasiloxane, Butylene Glycol, Glycerin, Niacinamide, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone,PEG-10 Dimethicone, Aluminum Hydroxide, Magnesium Sulfate, Stearic Acid, Disteardimonium Hectorite, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Polyhydroxystearic Acid , Caprylyl Glycol, Methyl Methacrylate Crosspolymer, Allantoin, Tocopheryl Acetate, Lecithin, Ethylhexyl Palmitate, Isostearic Acid, Isopropyl Myristate, Iron Oxides (CI 77491), Caprylhydroxamic Acid, Triethoxycaprylylsilane, Adenosine, Polyglyceryl-3 Polyricinoleate, Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Biosaccharide Gum-1, Sophora Japonica Fruit Extract, Pancratium Maritimum Extract, Fragrance

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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