Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3fb42cbd-8198-4163-a03d-146993f88aad
Route
CUTANEOUS
Published
Effective Date 2011-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.5 g) Titanium (2.05 g) Zinc Cation (1.42 g)
Inactive Ingredients
Water Cyclomethicone 5 Kiwi Fruit Silicon Dioxide Squalane Propylene Glycol Sodium Chloride Sorbitan Sesquioleate Glycerin Triethoxycaprylylsilane Aluminum Hydroxide Stearic Acid Methylparaben Phenoxyethanol Propylparaben Trolamine Watermelon Prunus Mume Fruit Sodium Palmitoyl Proline Nymphaea Alba Flower Panthenol Disodium Cocoamphodiacetate Wheat Germ Saccharomyces Cerevisiae Hyaluronate Sodium

Identifiers & Packaging

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

Description

Active ingredients: OCTINOXATE 7%, TITANIUM DIOXIDE 4.1%, ZINC OXIDE 2.85%


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:

At the end of basic cosmetic care, apply in an adequate amount to body parts sensitive to UV radiation such as face, arms and legs, 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 4.1%, ZINC OXIDE 2.85%

Section 50565-1

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6

Inactive ingredients:

WATER, CYCLOPENTASILOXANE, ISOAMYL p-METHOXYCINNAMATE, CETYL PEG/PPG-10/1 DIMETHICONE, ACTINIDIA CHINENSIS (KIWI) FRUIT EXTRACT, SQUALANE, PROPYLENE GLYCOL, SODIUM CHLORIDE, SORBITAN SESQUIOLEATE, STEARALKONIUM HECTORITE, GLYCERIN, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-10 DIMETHICONE, OZOKERITE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, STEARIC ACID, DIMETHICONE/METHICONE COPOLYMER, POLYMETHYL METHACRYLATE, TRIETHANOLAMINE, CITRULLUS VULGARIS (WATERMELON) FRUIT EXTRACT, PRUNUS MUME FRUIT EXTRACT, SODIUM PALMITOYL PROLINE, NYMPHAEA ALBA FLOWER EXTRACT, PANTHENOL, DISODIUM COCOAMPHODIACETATE, TRITICUM VULGARE (WHEAT) GERM EXTRACT, SACCHAROMYCES CEREVISIAE EXTRACT, SODIUM HYALURONATE, PROPYLPARABEN, METHYLPARABEN, PHENOXYETHANOL, FRAGRANCE, SILICA

Section 51945-4

Section 55105-1

Purpose: Protects skin from UV rays.

Section 55106-9

Active ingredients: OCTINOXATE 7%, TITANIUM DIOXIDE 4.1%, ZINC OXIDE 2.85%


Structured Label Content

Indications and Usage (34067-9)

Indication and usage:

At the end of basic cosmetic care, apply in an adequate amount to body parts sensitive to UV radiation such as face, arms and legs, 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, ISOAMYL p-METHOXYCINNAMATE, CETYL PEG/PPG-10/1 DIMETHICONE, ACTINIDIA CHINENSIS (KIWI) FRUIT EXTRACT, SQUALANE, PROPYLENE GLYCOL, SODIUM CHLORIDE, SORBITAN SESQUIOLEATE, STEARALKONIUM HECTORITE, GLYCERIN, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-10 DIMETHICONE, OZOKERITE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, STEARIC ACID, DIMETHICONE/METHICONE COPOLYMER, POLYMETHYL METHACRYLATE, TRIETHANOLAMINE, CITRULLUS VULGARIS (WATERMELON) FRUIT EXTRACT, PRUNUS MUME FRUIT EXTRACT, SODIUM PALMITOYL PROLINE, NYMPHAEA ALBA FLOWER EXTRACT, PANTHENOL, DISODIUM COCOAMPHODIACETATE, TRITICUM VULGARE (WHEAT) GERM EXTRACT, SACCHAROMYCES CEREVISIAE EXTRACT, SODIUM HYALURONATE, PROPYLPARABEN, METHYLPARABEN, PHENOXYETHANOL, FRAGRANCE, SILICA

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 4.1%, ZINC OXIDE 2.85%


Advanced Ingredient Data


Raw Label Data

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