Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID b5e3e380-9b92-4015-a9b9-6f1263f0f9d8
Route
CUTANEOUS
Published
Effective Date 2011-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.5 mL) Titanium (1.24 mL)
Inactive Ingredients
Water Butylene Glycol Cyclomethicone 5 Glycerin Isononyl Isononanoate Myristyl Alcohol Polysorbate 80 Cetyl Alcohol Stearic Acid Steareth-21 Aloe Vera Leaf Dimethicone Purslane Sorbitan Monostearate Phenoxyethanol Potassium Cetyl Phosphate Aluminum Hydroxide Methylparaben 1,2-hexanediol C13-14 Isoparaffin Laureth-7 Butylparaben Green Tea Leaf Ethylhexyl Stearate Butylated Hydroxytoluene Trideceth-6 Hyaluronate Sodium Edetate Disodium

Identifiers & Packaging

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

Description

Active ingredients: OCTINOXATE 7%, TITANIUM DIOXIDE 2.48%


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 2.48%

Section 50565-1

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6

Inactive ingredients:

WATER, ISOAMYL p-METHOXYCINNAMATE, BUTYLENE GLYCOL, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CYCLOPENTASILOXANE, GLYCERIN, ISONONYL ISONONANOATE, MYRISTYL ALCOHOL, POLYSORBATE 80, CETYL ALCOHOL, STEARIC ACID, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, STEARETH-21, ALOE BARBADENSIS LEAF EXTRACT, BETA-GLUCAN, DIMETHICONE, PORTULACA OLERACEA EXTRACT, SORBITAN STEARATE, SODIUM POLYACRYLATE, POTASSIUM CETYL PHOSPHATE, ALUMINUM HYDROXIDE, 1,2-HEXANEDIOL, C13-14 ISOPARAFFIN, POLYACRYLAMIDE, LAURETH-7, CAMELLIA SINENSIS LEAF EXTRACT, ETHYLHEXYL STEARATE, BHT, TOCOPHERYL ACETATE, TRIDECETH-6, SODIUM HYALURONATE, DISODIUM EDTA, PHENOXYETHANOL, METHYLPARABEN, BUTYLPARABEN, FRAGRANCE

Section 51945-4

Section 55105-1

Purpose: Protects skin from UV rays.

Section 55106-9

Active ingredients: OCTINOXATE 7%, TITANIUM DIOXIDE 2.48%


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, BUTYLENE GLYCOL, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CYCLOPENTASILOXANE, GLYCERIN, ISONONYL ISONONANOATE, MYRISTYL ALCOHOL, POLYSORBATE 80, CETYL ALCOHOL, STEARIC ACID, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, STEARETH-21, ALOE BARBADENSIS LEAF EXTRACT, BETA-GLUCAN, DIMETHICONE, PORTULACA OLERACEA EXTRACT, SORBITAN STEARATE, SODIUM POLYACRYLATE, POTASSIUM CETYL PHOSPHATE, ALUMINUM HYDROXIDE, 1,2-HEXANEDIOL, C13-14 ISOPARAFFIN, POLYACRYLAMIDE, LAURETH-7, CAMELLIA SINENSIS LEAF EXTRACT, ETHYLHEXYL STEARATE, BHT, TOCOPHERYL ACETATE, TRIDECETH-6, SODIUM HYALURONATE, DISODIUM EDTA, PHENOXYETHANOL, METHYLPARABEN, BUTYLPARABEN, 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 2.48%


Advanced Ingredient Data


Raw Label Data

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