SPL v2
SPL
SPL Set ID 2a41fdd9-9fa4-4e10-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (0.6 g) Titanium Dioxide (2.835 g) Zinc Oxide (0.3 g) Dimethicone
Inactive Ingredients
Ultramarine Blue Magnesium Sulfate Edetate Disodium Hyaluronate Sodium Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Lilium Candidum Flower Borago Officinalis Whole Carnauba Wax Water Nelumbo Nucifera Flower Oil Cyclomethicone 6 Octinoxate Dicaprylyl Carbonate Diphenylsiloxy Phenyl Trimethicone Cyclomethicone Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Ceresin Ceramide 3 Aspalathus Linearis Whole Centaurea Cyanus Flower Chamaemelum Nobile Flower Cyclomethicone 5 Phenoxyethanol Hexyldecyl Myristoyl Methylaminopropionate Maltitol Disteardimonium Hectorite Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Tribehenin Aluminum Hydroxide Ethylhexylglycerin Boron Nitride Ascorbic Acid Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-01-14

Description

Dimethicone 1.00%, Ethylhexyl Methoxycinnamate 4.00%, Glycerin 2.00%, Titanium Dioxide 9.45%, Zinc Oxide 1.00%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Dimethicone 1.00%, Ethylhexyl Methoxycinnamate 4.00%, Glycerin 2.00%, Titanium Dioxide 9.45%, Zinc Oxide 1.00%

Use

SPF20 PA++

4-in-1 makeip base for healthy skin tone and clean and balanced skin.

Caution

For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

Directions

After using our basic skin care products, apply an appropriate amount evenly to the face and gently pat to have an smooth finish.

Active Ingredients

Dimethicone 1.00%, Ethylhexyl Methoxycinnamate 4.00%, Glycerin 2.00%, Titanium Dioxide 9.45%, Zinc Oxide 1.00%

Inactive Ingredients

Water, Cyclopentasiloxane, Nelumbo Nucifera Flower Water, Cyclohexasiloxane, Diphenylsiloxy Phenyl Trimethicone, Cyclomethicone, PEG10 Dimethicone, Dicaprylyl Carbonate, Hexyldecyl Myristoyl Methylaminopropionate, Maltitol, Disteardimonium Hectorite, Ultramarines (CI 77007), Magnesium Sulfate, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Tribehenin, Cetyl PEG/PPG10/1 Dimethicone, Ceresin, Fragrance(Parfum), Triethoxycaprylylsilane, Methyl Methacrylate Crosspolymer, Aluminum Hydroxide, Ethylhexylglycerin, Disodium EDTA, Boron Nitride, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hydrolyzed Collagen, Ceramide 3, Sodium Hyaluronate, Ascorbic Acid, Butylene Glycol, Polysilicone11, Aspalathus Linearis Extract, Lilium Candidum Flower Extract, Borago Officinalis Extract, Salvia Officinalis (Sage) Leaf Extract, Centaurea Cyanus Flower Extract, Anthemis Nobilis Flower Extract, Trimethylsiloxysilicate, Copernicia Cerifera (Carnauba) Wax

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.


Structured Label Content

Use

SPF20 PA++

4-in-1 makeip base for healthy skin tone and clean and balanced skin.

Caution

For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

Purpose

Skin Protectant

Directions

After using our basic skin care products, apply an appropriate amount evenly to the face and gently pat to have an smooth finish.

Active Ingredients

Dimethicone 1.00%, Ethylhexyl Methoxycinnamate 4.00%, Glycerin 2.00%, Titanium Dioxide 9.45%, Zinc Oxide 1.00%

Inactive Ingredients

Water, Cyclopentasiloxane, Nelumbo Nucifera Flower Water, Cyclohexasiloxane, Diphenylsiloxy Phenyl Trimethicone, Cyclomethicone, PEG10 Dimethicone, Dicaprylyl Carbonate, Hexyldecyl Myristoyl Methylaminopropionate, Maltitol, Disteardimonium Hectorite, Ultramarines (CI 77007), Magnesium Sulfate, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Tribehenin, Cetyl PEG/PPG10/1 Dimethicone, Ceresin, Fragrance(Parfum), Triethoxycaprylylsilane, Methyl Methacrylate Crosspolymer, Aluminum Hydroxide, Ethylhexylglycerin, Disodium EDTA, Boron Nitride, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hydrolyzed Collagen, Ceramide 3, Sodium Hyaluronate, Ascorbic Acid, Butylene Glycol, Polysilicone11, Aspalathus Linearis Extract, Lilium Candidum Flower Extract, Borago Officinalis Extract, Salvia Officinalis (Sage) Leaf Extract, Centaurea Cyanus Flower Extract, Anthemis Nobilis Flower Extract, Trimethylsiloxysilicate, Copernicia Cerifera (Carnauba) Wax

Principal Display Panel

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.


Advanced Ingredient Data


Raw Label Data

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