SPL v1
SPL
SPL Set ID b0a56202-c575-4e3e-a5b0-ebaae21acb52
Route
TOPICAL
Published
Effective Date 2014-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (1.17 g) Octinoxate (0.91 g) Octisalate (0.62 g) Octocrylene (0.26 g) Zinc Cation
Inactive Ingredients
Water C12-15 Alkyl Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-08-01

Description

ACTIVE INGREDIENTS: Titanium Dioxide 9.0055%, Ethylhexyl Methoxycinnamate 7%, Ethylhexyl Salicylate 4.8%, Octocrylene 2%, Zinc Oxide 2%

Purpose

PURPOSE: UVA/UVB Protection


Medication Information

Purpose

PURPOSE: UVA/UVB Protection

Description

ACTIVE INGREDIENTS: Titanium Dioxide 9.0055%, Ethylhexyl Methoxycinnamate 7%, Ethylhexyl Salicylate 4.8%, Octocrylene 2%, Zinc Oxide 2%

Warnings

WARNINGS:

1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itcihng, irritation, or symtoms on applied skin under direct sunlight.

2. Do not use on scarred skin, or if you have dermatitis or eczema

3. Keep the cap close on its product

4. Keep away from direct sunlight or heat.

5. This product blocks UVA rays and ultraviolet protection effectiveness have been measured by the Food and Drug Administration methods and standards

Active Ingredient

ACTIVE INGREDIENTS: Titanium Dioxide 9.0055%, Ethylhexyl Methoxycinnamate 7%, Ethylhexyl Salicylate 4.8%, Octocrylene 2%, Zinc Oxide 2%

Inactive Ingredient

INACTIVE INGREDIENTS:

Water, Cyclopentasiloxane, C12-15 Alkyl benzoate, Cyclohexasiloxane, Glycerin, Niacinamide, PEG-30 Dipolyhydroxystearate, Quaternium-18 Bentonite, PEG-10 Dimethicone, Butylene Glycol, Sodium Chloride, Dimethicone, Iron Oxides (CI 77492), Ozokerite, Copernicia Cerifera (Carnauba) Wax, Iron Oxides (CI 77491), Chlorphenesin, Perfume, Aluminum Hydroxide, Triethoxycaprylylsilane, Iron Oxides (CI 77499), Adenosine, Centella Asiatica Extract, Portulaca Oleracea Extract, Vitex Agnus Castus Extract, Chamomilla Recutita (Matricaria) Flower

Indications & Usage

INDICATION & USAGE:

At the step of base make-up, tap the products gentlely on your face with the puff and let it absorb.

Dosage & Administration

DOSAGE & ADMINISTRATION:

At the stage of base make-up, apply it a suitable amount by using the provided applier.

Keep Out of Reach of Children

Keep out of reach of children: Keep out of reach of babies and children

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

PURPOSE: UVA/UVB Protection

Warnings (WARNINGS)

WARNINGS:

1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itcihng, irritation, or symtoms on applied skin under direct sunlight.

2. Do not use on scarred skin, or if you have dermatitis or eczema

3. Keep the cap close on its product

4. Keep away from direct sunlight or heat.

5. This product blocks UVA rays and ultraviolet protection effectiveness have been measured by the Food and Drug Administration methods and standards

Active Ingredient (ACTIVE INGREDIENT)

ACTIVE INGREDIENTS: Titanium Dioxide 9.0055%, Ethylhexyl Methoxycinnamate 7%, Ethylhexyl Salicylate 4.8%, Octocrylene 2%, Zinc Oxide 2%

Inactive Ingredient (INACTIVE INGREDIENT)

INACTIVE INGREDIENTS:

Water, Cyclopentasiloxane, C12-15 Alkyl benzoate, Cyclohexasiloxane, Glycerin, Niacinamide, PEG-30 Dipolyhydroxystearate, Quaternium-18 Bentonite, PEG-10 Dimethicone, Butylene Glycol, Sodium Chloride, Dimethicone, Iron Oxides (CI 77492), Ozokerite, Copernicia Cerifera (Carnauba) Wax, Iron Oxides (CI 77491), Chlorphenesin, Perfume, Aluminum Hydroxide, Triethoxycaprylylsilane, Iron Oxides (CI 77499), Adenosine, Centella Asiatica Extract, Portulaca Oleracea Extract, Vitex Agnus Castus Extract, Chamomilla Recutita (Matricaria) Flower

Indications & Usage (INDICATIONS & USAGE)

INDICATION & USAGE:

At the step of base make-up, tap the products gentlely on your face with the puff and let it absorb.

Dosage & Administration (DOSAGE & ADMINISTRATION)

DOSAGE & ADMINISTRATION:

At the stage of base make-up, apply it a suitable amount by using the provided applier.

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

Keep out of reach of children: Keep out of reach of babies and children

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)