SPL v1
SPL
SPL Set ID ecff440b-c4be-4e64-81f8-e6c82c50b108
Route
TOPICAL
Published
Effective Date 2017-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (6.65 g) Octocrylene (3.50 g) Octisalate (3.15 g) Avobenzone (2.10 g)
Inactive Ingredients
Water Dipropylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-02-10

Description

Active Ingredient: Homosalate 9.5%, Octocrylene 5.0%, Ethylhexyl Salicylate 4.5%, Butyl Methoxydibenzoylmethane 3.0%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Active Ingredient: Homosalate 9.5%, Octocrylene 5.0%, Ethylhexyl Salicylate 4.5%, Butyl Methoxydibenzoylmethane 3.0%

Warnings

Warning: For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions: Take an appropriate amount and apply thinly to the face and neck which is likely to be exposed to UV rays at the final stage of skin care. Finish by tapping lightly. Apply liberally 15 min before sun exposure. Reapply after 40min of swimming or sweating.

Active Ingredient

Active Ingredient: Homosalate 9.5%, Octocrylene 5.0%, Ethylhexyl Salicylate 4.5%, Butyl Methoxydibenzoylmethane 3.0%

Inactive Ingredient

Inactive Ingredients: Water, Dipropylene Glycol, Glycerin, Niacinamide, Propanediol, Dimethicone/Vinyl Dimethicone Crosspolymer, Hydrolyzed Wheat Protein/PVP Crosspolymer, Argania SpinosaKernel Oil, Betula Alba Juice, Avena Sativa (Oat) Kernel Extract, Honey Extract, Vanilla Tahitensis Fruit Extract, Portu laca Oleracea Extract, Caprylyl Methicone, Perlite, Dicaprylyl Carbonate, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetearyl Glucoside, Hydroxyacetophenone, Panthenol, Tocopheryl Acetate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Dipotassium Glycyrrhizate, Adenosine, Sorbitan Oleate, Isoceteth-10, Isoceteth-25, Sodium Phytate, Ethylhexylglycerin, Butylene Glycol, 1,2-Hexanediol, Cetearyl Alcohol, Xanthan Gum, Disodium EDTA, Phenoxyethanol, Potassium Sorbate, Fragrance(Parfum), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warning: For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions: Take an appropriate amount and apply thinly to the face and neck which is likely to be exposed to UV rays at the final stage of skin care. Finish by tapping lightly. Apply liberally 15 min before sun exposure. Reapply after 40min of swimming or sweating.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Homosalate 9.5%, Octocrylene 5.0%, Ethylhexyl Salicylate 4.5%, Butyl Methoxydibenzoylmethane 3.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Water, Dipropylene Glycol, Glycerin, Niacinamide, Propanediol, Dimethicone/Vinyl Dimethicone Crosspolymer, Hydrolyzed Wheat Protein/PVP Crosspolymer, Argania SpinosaKernel Oil, Betula Alba Juice, Avena Sativa (Oat) Kernel Extract, Honey Extract, Vanilla Tahitensis Fruit Extract, Portu laca Oleracea Extract, Caprylyl Methicone, Perlite, Dicaprylyl Carbonate, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetearyl Glucoside, Hydroxyacetophenone, Panthenol, Tocopheryl Acetate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Dipotassium Glycyrrhizate, Adenosine, Sorbitan Oleate, Isoceteth-10, Isoceteth-25, Sodium Phytate, Ethylhexylglycerin, Butylene Glycol, 1,2-Hexanediol, Cetearyl Alcohol, Xanthan Gum, Disodium EDTA, Phenoxyethanol, Potassium Sorbate, Fragrance(Parfum), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

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


Advanced Ingredient Data


Raw Label Data

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