SPL v1
SPL
SPL Set ID 1bcd928e-b137-4551-b53f-ac0bb798f427
Route
TOPICAL
Published
Effective Date 2012-10-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.81 g) Octinoxate (0.57 g) Zinc Oxide (0.28 g)
Inactive Ingredients
Talc Mica Magnesium Myristate Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-03-01

Description

ACTIVE INGREDIENTS: Titanium Dioxide 8.54%, Ethylhexyl Methoxycinnamate 6%, Zinc Oxide 2.94%

Indications and Usage

INDICATION AND USAGE: Step 1. Take an appropriate amount of powder onto vibrating puff and dab it on forehead, cheek and chin. Step 2. Turn on the vibrating puff and spread the powder evenly on face. Step 3. Turn off the vibrating puff to stop. - How to replace the puff Step 1. Hold the body of vibrating puff and slowly pull out the end to separate. Step 2. Place the new puff in the casing. Step 3. Press down on the puff to fix and arrange the edges. - How to replace the battery Step 1. Hold the body of vibrating puff and slowly pull out the end to separate. Step 2. Twist the body of vibrating puff to separate. (Do not twist the vibrator inside to avoid damage) Step 3. Replace Lithium battery.

Purpose

PURPOSE: This combination of Cosmetic / OTC Drug can be used as a sunscreen and as a cosmetic to cover your blemishes / scar and to tone up your skin care.

Dosage and Administration

DOSAGE AND ADMINISTRATION: Take appropriate amount according to your skin condition and apply as you desire. Remove it before sleeping.


Medication Information

Indications and Usage

INDICATION AND USAGE:

Step 1. Take an appropriate amount of powder onto vibrating puff and dab it on forehead, cheek and chin.

Step 2. Turn on the vibrating puff and spread the powder evenly on face.

Step 3. Turn off the vibrating puff to stop.

- How to replace the puff

Step 1. Hold the body of vibrating puff and slowly pull out the end to separate.

Step 2. Place the new puff in the casing.

Step 3. Press down on the puff to fix and arrange the edges.

- How to replace the battery

Step 1. Hold the body of vibrating puff and slowly pull out the end to separate.

Step 2. Twist the body of vibrating puff to separate. (Do not twist the vibrator inside to avoid damage)

Step 3. Replace Lithium battery.

Purpose

PURPOSE: This combination of Cosmetic / OTC Drug can be used as a sunscreen and as a cosmetic to cover your blemishes / scar and to tone up your skin care.

Dosage and Administration

DOSAGE AND ADMINISTRATION:

Take appropriate amount according to your skin condition and apply as you desire.

Remove it before sleeping.

Description

ACTIVE INGREDIENTS: Titanium Dioxide 8.54%, Ethylhexyl Methoxycinnamate 6%, Zinc Oxide 2.94%

Warnings

WARNING:

For external use only.

Do not swallow.

Keep out of reach of children.

Avoid contact with eyes.

Do not use on exposed wounds or if you are allergic to any ingredients of this product.

Active Ingredient

ACTIVE INGREDIENTS: Titanium Dioxide 8.54%, Ethylhexyl Methoxycinnamate 6%, Zinc Oxide 2.94%

Inactive Ingredient

INACTIVE INGREDIENTS:

Talc, Mica, Nylon-12, Silica, Methyl Methacrylate Crosspolymer, Magnesium Myristate, Diisostearyl Malate, Phenyl Trimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Synthetic Beeswax, Pearl Powder, Plukenetia Volubilis Seed Oil, Lilium Candidum Flower Extract, Iris Versicolor Extract, Leontopodium Alpinum Flower/Leaf Extract, Nelumbo Nucifera Flower Extract, Rose Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Freesia Refracta Extract, Narcissus Pseudo-Narcissus (Daffodil) Flower Extract, Triethylhexanoin, Magnesium Stearate, Triethoxycaprylylsilane, Dimethicone, Methicone, Ethylhexylglycerin, Glyceryl Caprylate, Stearic Acid, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Phytosterols, Sodium Hyaluronate, Water, Butylene Glycol, Cetearyl Alcohol, Fragrance(Parfum), Iron Oxides

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label. Principal Display Panel


Structured Label Content

Purpose (PURPOSE)

PURPOSE: This combination of Cosmetic / OTC Drug can be used as a sunscreen and as a cosmetic to cover your blemishes / scar and to tone up your skin care.

Warnings (WARNINGS)

WARNING:

For external use only.

Do not swallow.

Keep out of reach of children.

Avoid contact with eyes.

Do not use on exposed wounds or if you are allergic to any ingredients of this product.

Active Ingredient (ACTIVE INGREDIENT)

ACTIVE INGREDIENTS: Titanium Dioxide 8.54%, Ethylhexyl Methoxycinnamate 6%, Zinc Oxide 2.94%

Inactive Ingredient (INACTIVE INGREDIENT)

INACTIVE INGREDIENTS:

Talc, Mica, Nylon-12, Silica, Methyl Methacrylate Crosspolymer, Magnesium Myristate, Diisostearyl Malate, Phenyl Trimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Synthetic Beeswax, Pearl Powder, Plukenetia Volubilis Seed Oil, Lilium Candidum Flower Extract, Iris Versicolor Extract, Leontopodium Alpinum Flower/Leaf Extract, Nelumbo Nucifera Flower Extract, Rose Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Freesia Refracta Extract, Narcissus Pseudo-Narcissus (Daffodil) Flower Extract, Triethylhexanoin, Magnesium Stearate, Triethoxycaprylylsilane, Dimethicone, Methicone, Ethylhexylglycerin, Glyceryl Caprylate, Stearic Acid, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Phytosterols, Sodium Hyaluronate, Water, Butylene Glycol, Cetearyl Alcohol, Fragrance(Parfum), Iron Oxides

Indications and Usage (INDICATIONS AND USAGE)

INDICATION AND USAGE:

Step 1. Take an appropriate amount of powder onto vibrating puff and dab it on forehead, cheek and chin.

Step 2. Turn on the vibrating puff and spread the powder evenly on face.

Step 3. Turn off the vibrating puff to stop.

- How to replace the puff

Step 1. Hold the body of vibrating puff and slowly pull out the end to separate.

Step 2. Place the new puff in the casing.

Step 3. Press down on the puff to fix and arrange the edges.

- How to replace the battery

Step 1. Hold the body of vibrating puff and slowly pull out the end to separate.

Step 2. Twist the body of vibrating puff to separate. (Do not twist the vibrator inside to avoid damage)

Step 3. Replace Lithium battery.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

DOSAGE AND ADMINISTRATION:

Take appropriate amount according to your skin condition and apply as you desire.

Remove it before sleeping.

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

KEEP OUT OF REACH OF CHILDREN

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


Advanced Ingredient Data


Raw Label Data

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