Bc1169

Bc1169
SPL v1
SPL
SPL Set ID e8afa7d0-b25e-42ac-9eaa-81d6ad73b790
Route
TOPICAL
Published
Effective Date 2012-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.75 g) Avobenzone (1.5 g) Oxybenzone
Inactive Ingredients
Water Butylene Glycol Glycerin Isononyl Isononanoate Dimethicone Cetearyl Glucoside Pentylene Glycol Butyl Stearate Tridecyl Salicylate Cetyl Ricinoleate Cyclomethicone 5 Narcissus Tazetta Bulb Trifolium Pratense Flower Hyaluronate Sodium Tocopherol .alpha.-tocopherol Acetate Caprylyl Glycol Ethylhexyl Palmitate Glyceryl Monostearate Sodium Pyrrolidone Carboxylate Trehalose Urea Ammonium Acryloyldimethyltaurate/vp Copolymer Peg-100 Stearate Peg-8 Laurate Sodium Dodecylbenzenesulfonate Hexylene Glycol Isododecane Polyethylene Glycol 400 Xanthan Gum Nylon-12 Butylated Hydroxytoluene Edetate Disodium Mica Stannic Oxide Silica Dimethyl Silylate Benzyl Salicylate Butylphenyl Methylpropional Hydroxyisohexyl 3-cyclohexene Carboxaldehyde Benzoic Acid Butylparaben Isobutylparaben Methylparaben Phenoxyethanol Potassium Sorbate Propylparaben Sorbic Acid Chlorphenesin Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-11-15

Description

This multi-benefit moisturizer for dry skin provides intense hydration. Leaves skin feeling soft and smooth.

Indications and Usage

To Use: Smooth onto cleansed face and throat. Directions For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Sun Protection Measures. Spending time in the sun increases your risk of measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection hats, and sunglasses. Children under 6 months ask a doctor.

Purpose

Provides SPF 15 Sun Protection.

Dosage and Administration

Smooth on to face and throat.


Medication Information

Indications and Usage

To Use: Smooth onto cleansed face and throat.

Directions For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Sun Protection Measures. Spending time in the sun increases your risk of measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection hats, and sunglasses.

Children under 6 months ask a doctor.

Purpose

Provides SPF 15 Sun Protection.

Dosage and Administration

Smooth on to face and throat.

Description

This multi-benefit moisturizer for dry skin provides intense hydration. Leaves skin feeling soft and smooth.

Section 51945-4

Warnings

Warnings: For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.

When Using

Keep out of eyes.

Otc Purpose

Provides SPF 15 Sun Protection.

Inactive Ingredient

Inactive Ingredients: Water/Aqua/Eau, Butylene Glycol, Glycerin, Isononyl Isononanoate, Dimethicone, Cetearyl Glucoside, Pentylene Glycol, Butyl Stearate, Tridecyl Salicylate, Cetyl Ricinoleate, Cyclopentasiloxane, Narcissus Tazetta Bulb Extrat, Trifolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Tocopherol, Tocopheryl Acetate, Caprylyl Glycol, Cetearyl Dimethicone Crosspolymer, Ethylhexyl Palmitate, Glyceryl Stearate, Sodium PCA, Trehalose, Urea, Hyrdolyzed Soy Protein, Lecithin, Phospholipids, Polyphophorylcholine Glycol Acrylate, Ammonium Acryloyldimethylaurate/VP Coplymer, PEG-100 Stearate, PEG-8 Laurate, PEG-60 Hydrogenated Castor Oil, Sodium Dodecylbenzenesulfonate, Polyquaternium-51, Styrene/Acrylates Copolymer, Hexylene Glycol, Isododecane, PEG-8, Xanthan Gum, Nylon-12, BHT, Disodium EDTA, Mica, Tin Oxide, Silica Dimethyl Silylate, Parfum/Fragrance, Benzyl Salicylate, Butylphenyl Methylpropional, Citonellol, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limnene, Linalool, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Sorbic Acid, Chlorphenesin, Titanium Dioxide (CI 77891).

Otc Active Ingredient

Active Ingredients: Octinoxate 7.5%, Avobenzone 3.0%, Oxybenzone 3.0%.

Otc Keep Out of Reach of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Section 51945-4 (51945-4)

Warnings (WARNINGS)

Warnings: For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.

When Using (WHEN USING)

Keep out of eyes.

Description (DESCRIPTION)

This multi-benefit moisturizer for dry skin provides intense hydration. Leaves skin feeling soft and smooth.

Otc Purpose (OTC - PURPOSE)

Provides SPF 15 Sun Protection.

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Water/Aqua/Eau, Butylene Glycol, Glycerin, Isononyl Isononanoate, Dimethicone, Cetearyl Glucoside, Pentylene Glycol, Butyl Stearate, Tridecyl Salicylate, Cetyl Ricinoleate, Cyclopentasiloxane, Narcissus Tazetta Bulb Extrat, Trifolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Tocopherol, Tocopheryl Acetate, Caprylyl Glycol, Cetearyl Dimethicone Crosspolymer, Ethylhexyl Palmitate, Glyceryl Stearate, Sodium PCA, Trehalose, Urea, Hyrdolyzed Soy Protein, Lecithin, Phospholipids, Polyphophorylcholine Glycol Acrylate, Ammonium Acryloyldimethylaurate/VP Coplymer, PEG-100 Stearate, PEG-8 Laurate, PEG-60 Hydrogenated Castor Oil, Sodium Dodecylbenzenesulfonate, Polyquaternium-51, Styrene/Acrylates Copolymer, Hexylene Glycol, Isododecane, PEG-8, Xanthan Gum, Nylon-12, BHT, Disodium EDTA, Mica, Tin Oxide, Silica Dimethyl Silylate, Parfum/Fragrance, Benzyl Salicylate, Butylphenyl Methylpropional, Citonellol, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limnene, Linalool, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Sorbic Acid, Chlorphenesin, Titanium Dioxide (CI 77891).

Indications and Usage (INDICATIONS AND USAGE)

To Use: Smooth onto cleansed face and throat.

Directions For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Sun Protection Measures. Spending time in the sun increases your risk of measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection hats, and sunglasses.

Children under 6 months ask a doctor.

Otc Active Ingredient (OTC - ACTIVE INGREDIENT)

Active Ingredients: Octinoxate 7.5%, Avobenzone 3.0%, Oxybenzone 3.0%.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Smooth on to face and throat.

Otc Keep Out of Reach of Children (OTC - KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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