SPL v1
SPL
SPL Set ID 577e8f45-2b6a-4638-aac3-d150e6f03210
Route
TOPICAL
Published
Effective Date 2018-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (4.87 g) Titanium Dioxide (2.76 g) Octocrylene (1.95 g) Avobenzone (1.62 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-11-01

Description

Active ingredients: Ethylhexyl Methoxycinnamate 7.50%, Titanium2. Dioxide 4.25%, Octocrylene 3.00%, Butyl Methoxydibenzoylmethane 2.50%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses:

An anti-aging sunscreen cream prevent damage from UVA/UVB rays, and heat- aging while even skin’s texture and tone.

Directions:

Use Daily after basic skin care routine.

Apply liberally and frequently after sun exposure.

Warnings

Warnings:

For external use only

Avoid contact with eyes.

Discontinue use if signs of irritation or rashes appear.

Replace the cap after use.

Keep out of reach of children

Active Ingredient

Active ingredients: Ethylhexyl Methoxycinnamate 7.50%, Titanium2. Dioxide 4.25%, Octocrylene 3.00%, Butyl Methoxydibenzoylmethane 2.50%

Inactive Ingredient

Inactive ingredients:

Water, Butylene Glycol, Ethylhexyl Palmitate, Cyclopentasiloxane, Glycerin, 4-Methylbenzylidence Camphor, Arbutin, Cyclohexasiloxane, Cetearyl Alcohol, Polysorbate 60, Triceteareth-4 Phosphate, Glyceryl Stearate, PEG-100 Stearate, Glycol Stearate, Silica, Dimenthicone, Potassium Cetyl Phosphate, PEG-2 Stearate, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Phenoxyethanol, Methlyparaben, Beeswax, Fragrance (Parfum), Propylparaben, Adenosine, Iron Oxides (CI 77492), Disodium EDTA, Iron Oxides (CI 77491), Raspberry Seed Oil/ Tocopheryl Succinate Aminopropanediol, Dipropylene Glycol, Sodium Palmitoyl Proline, Nymphaea Alba Flower Extract, Lecithin, Aloe Barbadensis Leaf Extract, Alcohol, Buddleja Davidii Extract,Thymus Vulgaris (Thyme) Extract, Cassia Angustifolia Seed Polysaccharide, Polysorbate 80, Caprylic/ Capric Triglyceride, Sodium Ascorbyl Phosphate.

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings:

For external use only

Avoid contact with eyes.

Discontinue use if signs of irritation or rashes appear.

Replace the cap after use.

Keep out of reach of children

Description (DESCRIPTION)

Uses:

An anti-aging sunscreen cream prevent damage from UVA/UVB rays, and heat- aging while even skin’s texture and tone.

Directions:

Use Daily after basic skin care routine.

Apply liberally and frequently after sun exposure.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Ethylhexyl Methoxycinnamate 7.50%, Titanium2. Dioxide 4.25%, Octocrylene 3.00%, Butyl Methoxydibenzoylmethane 2.50%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Water, Butylene Glycol, Ethylhexyl Palmitate, Cyclopentasiloxane, Glycerin, 4-Methylbenzylidence Camphor, Arbutin, Cyclohexasiloxane, Cetearyl Alcohol, Polysorbate 60, Triceteareth-4 Phosphate, Glyceryl Stearate, PEG-100 Stearate, Glycol Stearate, Silica, Dimenthicone, Potassium Cetyl Phosphate, PEG-2 Stearate, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Phenoxyethanol, Methlyparaben, Beeswax, Fragrance (Parfum), Propylparaben, Adenosine, Iron Oxides (CI 77492), Disodium EDTA, Iron Oxides (CI 77491), Raspberry Seed Oil/ Tocopheryl Succinate Aminopropanediol, Dipropylene Glycol, Sodium Palmitoyl Proline, Nymphaea Alba Flower Extract, Lecithin, Aloe Barbadensis Leaf Extract, Alcohol, Buddleja Davidii Extract,Thymus Vulgaris (Thyme) Extract, Cassia Angustifolia Seed Polysaccharide, Polysorbate 80, Caprylic/ Capric Triglyceride, Sodium Ascorbyl Phosphate.

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)