Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 41219da4-5a95-4eaf-892d-51a1529029f7
Route
CUTANEOUS
Published
Effective Date 2011-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.75 g) Titanium (2 g)
Inactive Ingredients
Water Betula Platyphylla Var. Japonica Resin Propylene Glycol Butylene Glycol Arbutin Silicon Dioxide Cetyl Alcohol Cetyl Ethylhexanoate Stearic Acid Palmitic Acid Polysorbate 60 Sorbitan Sesquioleate Glyceryl Monostearate Dimethicone Adenosine Lecithin, Soybean Polysorbate 20 Sorbitan Monolaurate Propylene Glycol Monostearate Butylated Hydroxytoluene Trolamine Propylparaben Butylparaben Methylparaben Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-03-01

Description

Active ingredients: OCTINOXATE 7.5%, Titanium Dioxide 4%


Medication Information

Warnings and Precautions

Warnings:

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation appear.

Indications and Usage

Indication and usage:

After your daily skin care regimen, apply an even layer onto the face in upward and outward motions.

Dosage and Administration

Dosage and administration:

Dispense an ample amount and apply a thin layer onto the skin in outward and upward motions.

Description

Active ingredients: OCTINOXATE 7.5%, Titanium Dioxide 4%

Section 50565-1

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6

Inactive ingredients:

Water, Betula Platyphylla Japonica Juice, 4-Methylbenzylidene Camphor, Propylene Glycol, Butylene Glycol, Arbutin, Silica, Cetyl Alcohol, Cetyl Ethylhexanoate, Stearic Acid, Palmitic Acid, Polysorbate 60, Sorbitan Sesquioleate, Glyceryl Stearate, Tocopheryl Acetate, Dimethicone, Adenosine, Lecithin, Polysorbate 20, Sorbitan Laurate, Propylene Glycol Stearate, Propylene Glycol Laurate, Polyacrylate-13, Polyisobutene, Sorbitan Isostearate, BHT, Triethanolamine, Propylparaben, Butylparaben, Methylparaben, Phenoxyethanol, CI 77491, CI 77492, CI 77499

Section 51945-4

Section 55105-1

Purpose: Protects skin from UV rays.

Section 55106-9

Active ingredients: OCTINOXATE 7.5%, Titanium Dioxide 4%


Structured Label Content

Indications and Usage (34067-9)

Indication and usage:

After your daily skin care regimen, apply an even layer onto the face in upward and outward motions.

Dosage and Administration (34068-7)

Dosage and administration:

Dispense an ample amount and apply a thin layer onto the skin in outward and upward motions.

Warnings and Precautions (34071-1)

Warnings:

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation appear.

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, Betula Platyphylla Japonica Juice, 4-Methylbenzylidene Camphor, Propylene Glycol, Butylene Glycol, Arbutin, Silica, Cetyl Alcohol, Cetyl Ethylhexanoate, Stearic Acid, Palmitic Acid, Polysorbate 60, Sorbitan Sesquioleate, Glyceryl Stearate, Tocopheryl Acetate, Dimethicone, Adenosine, Lecithin, Polysorbate 20, Sorbitan Laurate, Propylene Glycol Stearate, Propylene Glycol Laurate, Polyacrylate-13, Polyisobutene, Sorbitan Isostearate, BHT, Triethanolamine, Propylparaben, Butylparaben, Methylparaben, Phenoxyethanol, CI 77491, CI 77492, CI 77499

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Protects skin from UV rays.

Section 55106-9 (55106-9)

Active ingredients: OCTINOXATE 7.5%, Titanium Dioxide 4%


Advanced Ingredient Data


Raw Label Data

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