SPL v1
SPL
SPL Set ID 293db80a-bbd6-4322-864c-8a8ed9be31f3
Route
TOPICAL
Published
Effective Date 2017-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (1.05 g) Octisalate (0.75 g) Titanium Dioxide (1.88 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-03-08

Description

Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Titanium Dioxide 12.5636%, Ethylhexyl Salicylate 5.0%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses: Press the sponge with built-in puff, take out proper quantity, then apply it along the skin texture, thin and wide, finish with massage.

Directions: following the use of base, take a suitable amount on the back of your hand and spread it over your face thinly flowing skin texture.

Warnings

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use.

Keep Out of Reach of Children: Do not use on hurt or abraded skin.

Active Ingredient

Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Titanium Dioxide 12.5636%, Ethylhexyl Salicylate 5.0%

Inactive Ingredient

Inactive ingredients: Water, Cyclopentasiloxane, Butylene Glycol, Lauryl PEG-8 Dimethicone, Ethylhexyl Isononanoate, Dipropylene Glycol, Niacinamide, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Diphenylsiloxy Phenyl Trimethicone, Mineral Water, Glacier Water, Panax Ginseng Root Oil, Poncirus Trifoliata Fruit Extract, Ginsenosides, Laetiporus Sulphureus Mycelium Extract, Panax Ginseng Root Extract, Panthenol, Hydrogenated Lecithin, Portulaca Oleracea Extract, Trapa Japonica Fruit Extract, Lilium Candidum Leaf Cell Extract, Nymphaea Coerulea Leaf Cell Extract, Nymphaea Alba Leaf Cell Extract, Aluminum Hydroxide, Barium Sulfate, Dimethicone, Magnesium Stearate, Sodium Citrate, Sodium Chloride, Silica, Trimethylsiloxysilicate, Stearic Acid, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Disteardimonium Hectorite, Stearalkonium Hectorite, Phenoxyethanol, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polyhydroxystearic Acid, Mica, Glyceryl Behenate, Polyglyceryl-6 Octastearate, Triethoxycaprylylsilane, Fragrance, Bismuth Oxychloride, Cetyl Dimethicone, Sodium Polyglutamate Crosspolymer, Caprylyl Glycol, Lecithin, C12-15 Alkyl Benzoate, Tribehenin, Ceramide 2, PEG-10 Rapeseed Sterol, Palmitoyl Oligopeptide, Ethylhexyl Palmitate, Isostearic Acid, Isopropyl Myristate, Polyglyceryl-3 Polyricinoleate, Dimethicone/Vinyl Dimethicone Crosspolymer, Diethyl Oxalate, Menthol, Adenosine, Glycerin, Caprylhydroxamic Acid, Disodium EDTA, Coral Powder, Pearl Powder, (+/-)CI 77492, CI 77491, CI 77499

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. Replace the cap after use.

Keep Out of Reach of Children: Do not use on hurt or abraded skin.

Description (DESCRIPTION)

Uses: Press the sponge with built-in puff, take out proper quantity, then apply it along the skin texture, thin and wide, finish with massage.

Directions: following the use of base, take a suitable amount on the back of your hand and spread it over your face thinly flowing skin texture.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Titanium Dioxide 12.5636%, Ethylhexyl Salicylate 5.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water, Cyclopentasiloxane, Butylene Glycol, Lauryl PEG-8 Dimethicone, Ethylhexyl Isononanoate, Dipropylene Glycol, Niacinamide, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Diphenylsiloxy Phenyl Trimethicone, Mineral Water, Glacier Water, Panax Ginseng Root Oil, Poncirus Trifoliata Fruit Extract, Ginsenosides, Laetiporus Sulphureus Mycelium Extract, Panax Ginseng Root Extract, Panthenol, Hydrogenated Lecithin, Portulaca Oleracea Extract, Trapa Japonica Fruit Extract, Lilium Candidum Leaf Cell Extract, Nymphaea Coerulea Leaf Cell Extract, Nymphaea Alba Leaf Cell Extract, Aluminum Hydroxide, Barium Sulfate, Dimethicone, Magnesium Stearate, Sodium Citrate, Sodium Chloride, Silica, Trimethylsiloxysilicate, Stearic Acid, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Disteardimonium Hectorite, Stearalkonium Hectorite, Phenoxyethanol, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polyhydroxystearic Acid, Mica, Glyceryl Behenate, Polyglyceryl-6 Octastearate, Triethoxycaprylylsilane, Fragrance, Bismuth Oxychloride, Cetyl Dimethicone, Sodium Polyglutamate Crosspolymer, Caprylyl Glycol, Lecithin, C12-15 Alkyl Benzoate, Tribehenin, Ceramide 2, PEG-10 Rapeseed Sterol, Palmitoyl Oligopeptide, Ethylhexyl Palmitate, Isostearic Acid, Isopropyl Myristate, Polyglyceryl-3 Polyricinoleate, Dimethicone/Vinyl Dimethicone Crosspolymer, Diethyl Oxalate, Menthol, Adenosine, Glycerin, Caprylhydroxamic Acid, Disodium EDTA, Coral Powder, Pearl Powder, (+/-)CI 77492, CI 77491, CI 77499

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


Advanced Ingredient Data


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