Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 7c0f359d-f89c-4fd6-855a-9463015b2fc9
Route
CUTANEOUS
Published
Effective Date 2011-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.5 mL) Octisalate (2.4 mL) Ensulizole (2 mL)
Inactive Ingredients
Water Butylene Glycol Alkyl (c12-15) Benzoate Cetostearyl Alcohol Glyceryl Monostearate Cetearyl Olivate Sorbitan Olivate Sodium Hydroxide Dimethicone Peg-100 Stearate Sorbitan Monostearate Panthenol Aloe Vera Leaf Polysorbate 20 Morus Alba Root Glycyrrhiza Glabra Cucumber Witch Hazel Purslane Nelumbo Nucifera Flower Bancha Tea Leaf/twig Dendranthema Indicum Flower Diospyros Kaki Leaf Pueraria Montana Var. Lobata Root Chinese Cinnamon Artemisia Princeps Leaf Butylated Hydroxytoluene Edetate Disodium 1,2-hexanediol Caprylyl Glycol Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-06-01

Description

Active ingredients: Octinoxate 7%, Octisalate 4.8%, Phenylbenzimidazole Sulfonic Acid 4%


Medication Information

Warnings and Precautions

WARNINGS:

For external use only.

Do not swallow.

Avoid contact with eyes.

Do not use on wounds or if you are allergic to any ingredients of this product.

Indications and Usage

INDICATION AND USAGE:

- At the last step of basic skin care, apply an appropriate amount evenly over the face. Pat lightly until fully absorbed.

- Apply evenly onto the face, neck, arms and legs where sun exposure occurs.

- Reapply during long exposure.

Dosage and Administration

DOSAGE AND ADMINISTRATION:

Take appropriate amount according to your skin condition and apply every morning and night.

Description

Active ingredients: Octinoxate 7%, Octisalate 4.8%, Phenylbenzimidazole Sulfonic Acid 4%

Section 50565-1

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6

INACTIVE INGREDIENTS:

Water, Butylene Glycol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Methyl Methacrylate Crosspolymer, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Glyceryl Stearate, Cetearyl Olivate, Sorbitan Olivate, Sodium Hydroxide, Dimethicone, Polyacrylate-13, PEG-100 Stearate, Polyisobutene, Sorbitan Stearate, Panthenol, Aloe Barbadensis Leaf Juice, Sorbitan Isostearate, Polysorbate 20, Morus Alba Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Cucumis Sativus (Cucumber) Fruit Extract, Hamamelis Virginiana (Witch Hazel) Water, Portulaca Oleracea Extract, Nelumbo Nucifera Flower Extract, Rosa Davurica Bud Extract, Camellia Sinensis Leaf Extract, Chrysanthemum Indicum flower Extract, Diospyros Kaki Leaf Extract, Pueraria Lobata Root Extract, Cinnamomum Cassia Bark Extract, Artemisia princeps Leaf Extract, Morus Alba Fruit Extract, BHT, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Ethylhexylglycerin

Section 51945-4

Section 55105-1

PURPOSE: This combination of Cosmetic / OTC Drug can be used as a sun protection cream

Section 55106-9

Active ingredients: Octinoxate 7%, Octisalate 4.8%, Phenylbenzimidazole Sulfonic Acid 4%


Structured Label Content

Indications and Usage (34067-9)

INDICATION AND USAGE:

- At the last step of basic skin care, apply an appropriate amount evenly over the face. Pat lightly until fully absorbed.

- Apply evenly onto the face, neck, arms and legs where sun exposure occurs.

- Reapply during long exposure.

Dosage and Administration (34068-7)

DOSAGE AND ADMINISTRATION:

Take appropriate amount according to your skin condition and apply every morning and night.

Warnings and Precautions (34071-1)

WARNINGS:

For external use only.

Do not swallow.

Avoid contact with eyes.

Do not use on wounds or if you are allergic to any ingredients of this product.

Section 50565-1 (50565-1)

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS:

Water, Butylene Glycol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Methyl Methacrylate Crosspolymer, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Glyceryl Stearate, Cetearyl Olivate, Sorbitan Olivate, Sodium Hydroxide, Dimethicone, Polyacrylate-13, PEG-100 Stearate, Polyisobutene, Sorbitan Stearate, Panthenol, Aloe Barbadensis Leaf Juice, Sorbitan Isostearate, Polysorbate 20, Morus Alba Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Cucumis Sativus (Cucumber) Fruit Extract, Hamamelis Virginiana (Witch Hazel) Water, Portulaca Oleracea Extract, Nelumbo Nucifera Flower Extract, Rosa Davurica Bud Extract, Camellia Sinensis Leaf Extract, Chrysanthemum Indicum flower Extract, Diospyros Kaki Leaf Extract, Pueraria Lobata Root Extract, Cinnamomum Cassia Bark Extract, Artemisia princeps Leaf Extract, Morus Alba Fruit Extract, BHT, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Ethylhexylglycerin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE: This combination of Cosmetic / OTC Drug can be used as a sun protection cream

Section 55106-9 (55106-9)

Active ingredients: Octinoxate 7%, Octisalate 4.8%, Phenylbenzimidazole Sulfonic Acid 4%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)