SPL v2
SPL
SPL Set ID 6cf4edab-0a7e-4f57-8ad7-ef3107eca7b8
Route
TOPICAL
Published
Effective Date 2015-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (0.36 g) Titanium Dioxide (0.06 g)
Inactive Ingredients
Petrolatum Diisostearyl Malate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-10-01

Description

Active Ingredients: Ethylhexyl Methoxycinnamate 5.00%, Titanium Dioxide 0.90%

Purpose

PURPOSE: Sunscreen


Medication Information

Purpose

PURPOSE: Sunscreen

Description

Active Ingredients: Ethylhexyl Methoxycinnamate 5.00%, Titanium Dioxide 0.90%

Warnings

Warnings: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

Active Ingredient

Active Ingredients: Ethylhexyl Methoxycinnamate 5.00%, Titanium Dioxide 0.90%

Inactive Ingredient

Inactive Ingredients: Polyglyceryl-2 Triisostearate, Petrolatum, Diisostearyl Malate, Bis-Diglyceryl Polyacyladipate-2, Polybutene, Benzophenone-3, Hydroxystearic Acid, Microcrystalline Wax, Silica Dimethyl Silylate, VP/Hexadecene Copolymer, Mica (CI 77019), Sorbitan Isostearate, Fragrance(Parfum), Red 6 (CI 15850), Butylparaben, Tocopheryl Acetate, Methicone, Yellow 5 Lake (CI 19140), Prunus Avium (Sweet Cherry) Fruit Extract, Water, Butylene Glycol, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract

Indications & Usage

INDICATIONS AND USAGE: Apply on lip with fingers

Dosage & Administration

DOSAGE AND ADMINISTRATION: Take an adequate amount of this product.

Keep Out of Reach of Children

Keep out of reach of children: Keep out of reach of babies and children

Package Label.principal Display Panel

Image of carton


Structured Label Content

Purpose (PURPOSE)

PURPOSE: Sunscreen

Warnings (WARNINGS)

Warnings: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredients: Ethylhexyl Methoxycinnamate 5.00%, Titanium Dioxide 0.90%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Polyglyceryl-2 Triisostearate, Petrolatum, Diisostearyl Malate, Bis-Diglyceryl Polyacyladipate-2, Polybutene, Benzophenone-3, Hydroxystearic Acid, Microcrystalline Wax, Silica Dimethyl Silylate, VP/Hexadecene Copolymer, Mica (CI 77019), Sorbitan Isostearate, Fragrance(Parfum), Red 6 (CI 15850), Butylparaben, Tocopheryl Acetate, Methicone, Yellow 5 Lake (CI 19140), Prunus Avium (Sweet Cherry) Fruit Extract, Water, Butylene Glycol, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract

Indications & Usage (INDICATIONS & USAGE)

INDICATIONS AND USAGE: Apply on lip with fingers

Dosage & Administration (DOSAGE & ADMINISTRATION)

DOSAGE AND ADMINISTRATION: Take an adequate amount of this product.

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

Keep out of reach of children: Keep out of reach of babies and children

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Image of carton


Advanced Ingredient Data


Raw Label Data

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