Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID be7ccf24-d63e-4f3f-9d7d-8e2ee8e691e6
Route
CUTANEOUS
Published
Effective Date 2011-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (2.5 mL) Octisalate (1.9 mL) Zinc Cation (1.44 mL) Titanium
Inactive Ingredients
Water Cyclomethicone 5 Alkyl (c12-15) Benzoate Bemotrizinol Diethylhexyl Carbonate Cetyl Octanoate Dimethicone Cyclomethicone 6 Peg-30 Dipolyhydroxystearate Sodium Chloride Propylene Carbonate Polyglyceryl-4 Isostearate Sorbitan Sesquioleate Hexyl Laurate Sorbitan Olivate Trimethoxycaprylylsilane Methylparaben Aloe Vera Leaf Broccoli Butylene Glycol Butylparaben Matricaria Recutita Purslane Propylene Glycol Edetate Disodium

Identifiers & Packaging

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

Description

Active ingredients: OCTINOXATE 5%, OCTISALATE 5%, ZINC OXIDE 3.8%, TITANIUM DIOXIDE 2.87%


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 5%, OCTISALATE 5%, ZINC OXIDE 3.8%, TITANIUM DIOXIDE 2.87%

Section 50565-1

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6

Inactive ingredients:

WATER, CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, DIETHYLHEXYL CARBONATE, ISOAMYL p-METHOXYCINNAMATE, CETYL CAPRYLATE, DIMETHICONE, CYCLOHEXASILOXANE, CETYL PEG/PPG-10/1 DIMETHICONE, STEARALKONIUM HECTORITE, POLYGLYCERYL-6 POLYHYDROXYSTEARATE,

PEG-30 DIPOLYHYDROXYSTEARATE, SODIUM CHLORIDE, PEG-10 DIMETHICONE, OZOKERITE, PROPYLENE CARBONATE, POLYGLYCERYL-4 ISOSTEARATE, SORBITAN SESQUIOLEATE, ALCOHOL DENAT., HEXYL LAURATE, SORBITAN OLIVATE, TRIMETHOXYCAPRYLYLSILANE, DIMETHICONE, ALOE BARBADENSIS LEAF EXTRACT, BRASSICA OLERACEA ITALICA (BROCCOLI) EXTRACT, BUTYLENE GLYCOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, PORTULACA OLERACEA EXTRACT, PROPYLENE GLYCOL, DISODIUM EDTA, METHYLPARABEN, BUTYLPARABEN, FRAGRANCE



Section 51945-4

Section 55105-1

Purpose: Protects skin from UV rays.

Section 55106-9

Active ingredients: OCTINOXATE 5%, OCTISALATE 5%, ZINC OXIDE 3.8%, TITANIUM DIOXIDE 2.87%


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, CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, DIETHYLHEXYL CARBONATE, ISOAMYL p-METHOXYCINNAMATE, CETYL CAPRYLATE, DIMETHICONE, CYCLOHEXASILOXANE, CETYL PEG/PPG-10/1 DIMETHICONE, STEARALKONIUM HECTORITE, POLYGLYCERYL-6 POLYHYDROXYSTEARATE,

PEG-30 DIPOLYHYDROXYSTEARATE, SODIUM CHLORIDE, PEG-10 DIMETHICONE, OZOKERITE, PROPYLENE CARBONATE, POLYGLYCERYL-4 ISOSTEARATE, SORBITAN SESQUIOLEATE, ALCOHOL DENAT., HEXYL LAURATE, SORBITAN OLIVATE, TRIMETHOXYCAPRYLYLSILANE, DIMETHICONE, ALOE BARBADENSIS LEAF EXTRACT, BRASSICA OLERACEA ITALICA (BROCCOLI) EXTRACT, BUTYLENE GLYCOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, PORTULACA OLERACEA EXTRACT, PROPYLENE GLYCOL, DISODIUM EDTA, 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 5%, OCTISALATE 5%, ZINC OXIDE 3.8%, TITANIUM DIOXIDE 2.87%


Advanced Ingredient Data


Raw Label Data

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