SPL v1
SPL
SPL Set ID 2ab403df-29b3-75af-e063-6394a90a6ca4
Route
TOPICAL
Published
Effective Date 2025-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (12.11 g) Octinoxate (5 g) Zinc Cation (2.93 g) Niacinamide (2 g) Adenosine (0.04 g)
Inactive Ingredients
Water Cyclomethicone 5 Phenyl Trimethicone

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-11-30

Description

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

Purpose

Sunscreen Sunscreen Sunscreen Skin Brightening Anti wrinkle


Medication Information

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%

Uses

■ Helps prevent sun burn

■ Helps brighten skin tone

■ Helps improve wrinkle problem

Section 51945-4

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.

Questions

■ www.ibiostar.com

■ Tel (424)227-9568

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.

Active Ingredients

Titanium Dioxide 12.11%

Ethylhexyl Methoxycinnamate 5.00%

Zinc Oxide 2.93%

Niacinamide 2.0%

Adenosine 0.04%

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

Keep Out of Reach of Children

Keep out of the reach of children.


Structured Label Content

Uses

■ Helps prevent sun burn

■ Helps brighten skin tone

■ Helps improve wrinkle problem

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Sunscreen

Sunscreen

Sunscreen

Skin Brightening

Anti wrinkle

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.

Questions

■ www.ibiostar.com

■ Tel (424)227-9568

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.

Active Ingredients (ACTIVE INGREDIENTS)

Titanium Dioxide 12.11%

Ethylhexyl Methoxycinnamate 5.00%

Zinc Oxide 2.93%

Niacinamide 2.0%

Adenosine 0.04%

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

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

Keep out of the reach of children.


Advanced Ingredient Data


Raw Label Data

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