Sunscreen Advance

Sunscreen Advance
SPL v2
SPL
SPL Set ID fe95fdbf-73df-a587-e053-6394a90a53a0
Route
TOPICAL
Published
Effective Date 2022-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ensulizole (20 mg) Titanium Dioxide (16 mg) Octisalate (50 mg) Polysilicone-15 (100 mg) Octocrylene Avobenzone
Inactive Ingredients
Water Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Cetostearyl Alcohol Edetate Disodium Anhydrous Potassium Cetyl Phosphate Docosanol Hexadecyl Povidone Phenoxyethanol Diisopropyl Sebacate Xanthan Gum Silicon Dioxide Tromethamine Ethylhexylglycerin Bis-ethylhexyl Hydroxydimethoxy Benzylmalonate Butylene Glycol Alkyl (c12-15) Benzoate Butylene Glycol Dicaprylate/dicaprate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-26

Description

Cream-Gel: Plastic Tube, 50 g

Purpose

Sunscreen

Dosage and Administration

Apply a sufficient amount of the sunscreen about 15 minutes before sun exposure on intact skin and massage gently. Reapply every 2 hours, after swimming, or sport.

Contraindications

Hypersensitivity to any of the components.


Medication Information

Purpose

Sunscreen

Dosage and Administration

Apply a sufficient amount of the sunscreen about 15 minutes before sun exposure on intact skin and massage gently. Reapply every 2 hours, after swimming, or sport.

Contraindications

Hypersensitivity to any of the components.

Description

Cream-Gel: Plastic Tube, 50 g

Warnings

- If irritation occurs, immediately rinse with water and discontinue use.

- If irritation persists, consult with a physician.

- Keep away from your eyes, in case of eye contact, flush with water.

- For external use only.

Properties

This product is developed to be suitable for all types of skin, with high sun protection factors (SPF 50 +) and optimum combination of UVB/UVA filters, they efficiently protect the skin pigmentation spots and skin ageing.

It is fast absorbing with dry touch and matte feel for optimal protection without leaving any white residue on skin.

Paraben Free, Water resistant.

Indications

Sunscreen for all skin types

Precautions

Keep out of reach of children

Side Effects

There are no known side effects.

Primary Package

Secondary Package

Active Ingredients

Octocrylene, Butyl Methoxydibenzoylmethane (Avobenzone), Ethylhexyl Salicylate, Phenylbenzimidazole Sulfonic Acid, Polysilicone-15, Titanium Dioxide

Storage Conditions

Store below 30 C.

Inactive Ingredients

Aqua, Butylene Glycol Dicaprylate/Dicaprate, Potassium Cetyl Phosphate, Silica, Diisopropyl Sebacate, Butylene Glycol, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Behenyl Alcohol, Tromethamine, VP/Hexadecene Copolymer, Phenoxyethanol, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Ethylhexylglycerin

Form and Presentation

Cream-Gel: Plastic Tube, 50 g


Structured Label Content

Purpose

Sunscreen

Warnings

- If irritation occurs, immediately rinse with water and discontinue use.

- If irritation persists, consult with a physician.

- Keep away from your eyes, in case of eye contact, flush with water.

- For external use only.

Properties

This product is developed to be suitable for all types of skin, with high sun protection factors (SPF 50 +) and optimum combination of UVB/UVA filters, they efficiently protect the skin pigmentation spots and skin ageing.

It is fast absorbing with dry touch and matte feel for optimal protection without leaving any white residue on skin.

Paraben Free, Water resistant.

Indications

Sunscreen for all skin types

Precautions

Keep out of reach of children

Side Effects

There are no known side effects.

Primary Package

Contraindications

Hypersensitivity to any of the components.

Secondary Package

Active Ingredients

Octocrylene, Butyl Methoxydibenzoylmethane (Avobenzone), Ethylhexyl Salicylate, Phenylbenzimidazole Sulfonic Acid, Polysilicone-15, Titanium Dioxide

Storage Conditions

Store below 30 C.

Inactive Ingredients

Aqua, Butylene Glycol Dicaprylate/Dicaprate, Potassium Cetyl Phosphate, Silica, Diisopropyl Sebacate, Butylene Glycol, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Behenyl Alcohol, Tromethamine, VP/Hexadecene Copolymer, Phenoxyethanol, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Ethylhexylglycerin

Form and Presentation

Cream-Gel: Plastic Tube, 50 g

Dosage and Administration

Apply a sufficient amount of the sunscreen about 15 minutes before sun exposure on intact skin and massage gently. Reapply every 2 hours, after swimming, or sport.


Advanced Ingredient Data


Raw Label Data

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