32abb463-eb24-4ace-8bb7-23bf8a370e43

SPL v1
SPL
SPL Set ID 32abb463-eb24-4ace-8bb7-23bf8a370e43
Route
topical
Published
Effective Date 2022-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (12.11 g) octinoxate (5.00 g) zinc cation (2.93 g) niacinamide (2.00 g) adenosine (0.04 g)
Inactive Ingredients
water cyclomethicone 5 phenyl trimethicone

Identifiers & Packaging

Marketing Status
unapproved drug other active Since 2022-10-01

Purpose

Sunscreen Sunscreen Sunscreen Skin Brightening Anti wrinkle

Description

Titanium Dioxide 12.11% Ethylhexyl Methoxycinnamate 5.00% Zinc Oxide 2.93% Niacinamide 2.0% Adenosine 0.04%


Medication Information

Warnings

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation or rashes appear.

Replace the cap after use.

Refrain from using it on wounded areas.

Keep out of reach of children.

Uses

■ Helps prevent sun burn

■ Helps brighten skin tone

■ Helps improve wrinkle problem

Purpose

Sunscreen

Sunscreen

Sunscreen

Skin Brightening

Anti wrinkle

Directions

■ Apply an appropriate amount evenly on the skin.

■ Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure. Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light.

Inactive Ingredients

Water, Cyclopentasiloxane, Phenyl Trimethicone, Glycerin, Butylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Zinc Oxide (CI 77947), 1,2-Hexanediol, Tridecyl Trimellitate, Disteardimonium Hectorite, Mica (CI 77019), Iron Oxides (CI 77492), Trimethylsiloxysilicate, Cetyl PEG/PPG-10/1 Dimethicone, Human Adipose Derived Stem Cell Conditioned Media, Silica, Isododecane, Magnesium Sulfate, Dimethicone/Vinyl Dimethicone Crosspolymer, Cetyl Dimethicone, Dimethicone, Iron Oxides (CI 77491), Aluminum Hydroxide, Potassium Sorbate, Triethoxycaprylylsilane, Stearic Acid, Iron Oxides (CI 77499), Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Trisodium Ethylenediamine Disuccinate, Xanthan Gum, Hydrogenated Castor Oil Isostearate, Citrus Grandis (Grapefruit) Peel Oil, Tin Oxide (CI 77861), Hydrolyzed Hyaluronic Acid, Plukenetia Volubilis Seed Oil, Totarol, Butylene Glycol, Adansonia Digitata Pulp Extract, Hydrolyzed Algin, Cucumis Melo (Melon) Fruit Extract, Viscum Album (Mistletoe) Leaf Extract, Sodium Benzoate, BHT

Description

Titanium Dioxide 12.11% Ethylhexyl Methoxycinnamate 5.00% Zinc Oxide 2.93% Niacinamide 2.0% Adenosine 0.04%

Questions

■ www.ibiostar.com

■ Tel (424)227-9568

Active Ingredients

Titanium Dioxide 12.11%

Ethylhexyl Methoxycinnamate 5.00%

Zinc Oxide 2.93%

Niacinamide 2.0%

Adenosine 0.04%

Keep Out of Reach of Children

Keep out of the reach of children.

Package Label.principal Display Panel


Structured Label Content

Warnings (WARNINGS)

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation or rashes appear.

Replace the cap after use.

Refrain from using it on wounded areas.

Keep out of reach of children.

Uses

■ Helps prevent sun burn

■ Helps brighten skin tone

■ Helps improve wrinkle problem

Purpose (PURPOSE)

Sunscreen

Sunscreen

Sunscreen

Skin Brightening

Anti wrinkle

Directions

■ Apply an appropriate amount evenly on the skin.

■ Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure. Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light.

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Cyclopentasiloxane, Phenyl Trimethicone, Glycerin, Butylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Zinc Oxide (CI 77947), 1,2-Hexanediol, Tridecyl Trimellitate, Disteardimonium Hectorite, Mica (CI 77019), Iron Oxides (CI 77492), Trimethylsiloxysilicate, Cetyl PEG/PPG-10/1 Dimethicone, Human Adipose Derived Stem Cell Conditioned Media, Silica, Isododecane, Magnesium Sulfate, Dimethicone/Vinyl Dimethicone Crosspolymer, Cetyl Dimethicone, Dimethicone, Iron Oxides (CI 77491), Aluminum Hydroxide, Potassium Sorbate, Triethoxycaprylylsilane, Stearic Acid, Iron Oxides (CI 77499), Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Trisodium Ethylenediamine Disuccinate, Xanthan Gum, Hydrogenated Castor Oil Isostearate, Citrus Grandis (Grapefruit) Peel Oil, Tin Oxide (CI 77861), Hydrolyzed Hyaluronic Acid, Plukenetia Volubilis Seed Oil, Totarol, Butylene Glycol, Adansonia Digitata Pulp Extract, Hydrolyzed Algin, Cucumis Melo (Melon) Fruit Extract, Viscum Album (Mistletoe) Leaf Extract, Sodium Benzoate, BHT

Questions

■ www.ibiostar.com

■ Tel (424)227-9568

Active Ingredients (ACTIVE INGREDIENTS)

Titanium Dioxide 12.11%

Ethylhexyl Methoxycinnamate 5.00%

Zinc Oxide 2.93%

Niacinamide 2.0%

Adenosine 0.04%

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

Keep out of the reach of children.

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


Advanced Ingredient Data


Raw Label Data

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