Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 6d5b07ab-c0a2-4494-8b07-a73573ef71c4
Route
CUTANEOUS
Published
Effective Date 2011-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (5.25 mL) Titanium (2.47 mL)
Inactive Ingredients
Water Propylene Glycol Butylene Glycol Polysorbate 80 Diethylhexyl Carbonate Trimethoxycaprylylsilane Sorbitan Monolaurate Aluminum Hydroxide Stearic Acid Potassium Cetyl Phosphate Isohexadecane Dimethicone Phenoxyethanol Methylparaben Peach Propylparaben Chamomile Glycyrrhiza Glabra Centella Asiatica Soybean Apple Butylated Hydroxytoluene Trolamine Edetate Disodium

Identifiers & Packaging

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

Description

Active Ingredients: OCTINOXATE 7%, TITANIUM DIOXIDE 3.3%


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:

Use at the end of your daily skincare regimen. Apply liberally onto face and body before sun exposure avoiding the eye area.

Dosage and Administration

Dosage and administration:

For best results, apply at least 15 to 20 minutes before sun exposure.

Reapply frequently while out in the sun.

Description

Active Ingredients: OCTINOXATE 7%, TITANIUM DIOXIDE 3.3%

Section 50565-1

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6

Inactive ingredients:



WATER, ISOAMYL p-METHOXYCINNAMATE, PROPYLENE GLYCOL, BUTYLENE GLYCOL, POLYSORBATE 80, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, DIETHYLHEXYL CARBONATE, POLYGLYCERYL-6 POLYHYDROXYSTEARATE, RIMETHOXYCAPRYLYLSILANE, SORBITAN LAURATE, ALUMINUM HYDROXIDE, STEARIC ACID, POTASSIUM CETYL PHOSPHATE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, DIMETHICONE, PRUNUS PERSICA (PEACH) FRUIT EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CENTELLA ASIATICA EXTRACT, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, CARBOMER, BHT, TOCOPHERYL ACETATE, CAMELLIA SINENSIS LEAF EXTRACT, TRIETHANOLAMINE, DISODIUM EDTA, RICE FERMENT FILTRATE (SAKE), PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, FRAGRANCE

Section 51945-4

Section 55105-1

Purpose: Protects skin from UV rays.

Section 55106-9

Active Ingredients: OCTINOXATE 7%, TITANIUM DIOXIDE 3.3%


Structured Label Content

Indications and Usage (34067-9)

Indication and usage:

Use at the end of your daily skincare regimen. Apply liberally onto face and body before sun exposure avoiding the eye area.

Dosage and Administration (34068-7)

Dosage and administration:

For best results, apply at least 15 to 20 minutes before sun exposure.

Reapply frequently while out in the sun.

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, ISOAMYL p-METHOXYCINNAMATE, PROPYLENE GLYCOL, BUTYLENE GLYCOL, POLYSORBATE 80, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, DIETHYLHEXYL CARBONATE, POLYGLYCERYL-6 POLYHYDROXYSTEARATE, RIMETHOXYCAPRYLYLSILANE, SORBITAN LAURATE, ALUMINUM HYDROXIDE, STEARIC ACID, POTASSIUM CETYL PHOSPHATE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, DIMETHICONE, PRUNUS PERSICA (PEACH) FRUIT EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CENTELLA ASIATICA EXTRACT, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, CARBOMER, BHT, TOCOPHERYL ACETATE, CAMELLIA SINENSIS LEAF EXTRACT, TRIETHANOLAMINE, DISODIUM EDTA, RICE FERMENT FILTRATE (SAKE), PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, FRAGRANCE

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%, TITANIUM DIOXIDE 3.3%


Advanced Ingredient Data


Raw Label Data

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