SPL v1
SPL
SPL Set ID 2ab49052-085f-024e-e063-6394a90a81b8
Route
TOPICAL
Published
Effective Date 2025-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.3 g) Homosalate (6 g) Octisalate (4.5 g) Avobenzone (4 g) Ensulizole (3.5 g) Octocrylene (2 g) Bemotrizinol (1.5 g) Niacinamide (0.04 g) Adenosine
Inactive Ingredients
Water Butylene Glycol Dimethicone

Identifiers & Packaging

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

Description

Ethylhexyl Methoxycinnamate 7.30% Homosalate 6.00% Ethylhexyl Salicylate 4.50% Butyl Methoxydibenzoylmethane 4.00% Phenylbenzimidazole Sulfonic Acid 3.50% Octocrylene 2.00% Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine 1.50% Niacinamide 2.0% Adenosine 0.04%

Purpose

Sunscreen Sunscreen Sunscreen Sunscreen Sunscreen Sunscreen Sunscreen Skin Brightening Anti wrinkle


Medication Information

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Skin Brightening

Anti wrinkle

Description

Ethylhexyl Methoxycinnamate 7.30% Homosalate 6.00% Ethylhexyl Salicylate 4.50% Butyl Methoxydibenzoylmethane 4.00% Phenylbenzimidazole Sulfonic Acid 3.50% Octocrylene 2.00% Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine 1.50% 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

Ethylhexyl Methoxycinnamate 7.30%

Homosalate 6.00%

Ethylhexyl Salicylate 4.50%

Butyl Methoxydibenzoylmethane 4.00%

Phenylbenzimidazole Sulfonic Acid 3.50%

Octocrylene 2.00%

Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine 1.50%

Niacinamide 2.0%

Adenosine 0.04%

Inactive Ingredients

Water, Butylene Glycol, Dimethicone, Dipropylene Glycol, Hydrogenated Poly(C6-14 Olefin), Neopentyl Glycol Diheptanoate, Cyclopentasiloxane, Methyl Methacrylate Crosspolymer, Aminomethyl Propanol, Cyclohexasiloxane, Caprylyl Methicone, Human Adipose Derived Stem Cell Conditioned Media, Potassium Cetyl Phosphate, Triceteareth-4 Phosphate, Glycol Stearate, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Silica, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-2 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Glyceryl Caprylate, Santalum Album (Sandalwood) Oil, Caprylyl Glycol, Xanthan Gum, Polysorbate 60, Sorbitan Isostearate, Disodium EDTA, Hydroxypropyl Cyclodextrin, Plankton Extract, Thioctic Acid, 1,2-Hexanediol, Tremella Fuciformis (Mushroom) Extract, Potassium Hydroxide

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

Sunscreen

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)

Ethylhexyl Methoxycinnamate 7.30%

Homosalate 6.00%

Ethylhexyl Salicylate 4.50%

Butyl Methoxydibenzoylmethane 4.00%

Phenylbenzimidazole Sulfonic Acid 3.50%

Octocrylene 2.00%

Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine 1.50%

Niacinamide 2.0%

Adenosine 0.04%

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Butylene Glycol, Dimethicone, Dipropylene Glycol, Hydrogenated Poly(C6-14 Olefin), Neopentyl Glycol Diheptanoate, Cyclopentasiloxane, Methyl Methacrylate Crosspolymer, Aminomethyl Propanol, Cyclohexasiloxane, Caprylyl Methicone, Human Adipose Derived Stem Cell Conditioned Media, Potassium Cetyl Phosphate, Triceteareth-4 Phosphate, Glycol Stearate, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Silica, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-2 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Glyceryl Caprylate, Santalum Album (Sandalwood) Oil, Caprylyl Glycol, Xanthan Gum, Polysorbate 60, Sorbitan Isostearate, Disodium EDTA, Hydroxypropyl Cyclodextrin, Plankton Extract, Thioctic Acid, 1,2-Hexanediol, Tremella Fuciformis (Mushroom) Extract, Potassium Hydroxide

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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