SPL v1
SPL
SPL Set ID dc1979a5-f36a-4a8f-a2e5-7d3443eb2d6c
Route
TOPICAL
Published
Effective Date 2017-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.40 g) Octinoxate (2.25 g)
Inactive Ingredients
Water Phenyl Trimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-10-01

Description

Active ingredients: Titanium Dioxide 8.0%, Ethylhexyl Methoxycinnamate 7.5%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses: - Ultralight, Multifunctional beauty cream to protect, perfect, tint, and moisturize skin - Features SPF 33 PA+++ sun protection

Directions: Apply moderate amount on entire face after basic skin care.

Warnings

Warning: 1) For external use only. 2) Consult a dermatologist if the first sign occurs like red spot, swelling, itching, or any allergic reactions. 3) Avoid direct contact with eyes. 4) If contact occurs, flush thoroughly with water. 5) If swallowed, get medical help or contact a Poison Control Center right away. 6) Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Storage and cautions for handling: 1) Keep out of reach of children. 2) Keep away from high or low temperature and direct sunlight.

Active Ingredient

Active ingredients: Titanium Dioxide 8.0%, Ethylhexyl Methoxycinnamate 7.5%

Inactive Ingredient

Inactive ingredients: Water, Phenyl Trimethicone, Propylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Arbutin, Cyclopentasiloxane, Hexyl Laurate, Cyclohexasiloxane, Methyl Methacrylate Crosspolymer, Iron Oxides (CI 77492), Glycerin, Magnesium Sulfate, Sorbitan Sesquioleate, Zinc stearate, Caprylyl Methicone, Dimethicone, Microcrystalline Wax, Ozokerite, Isostearyl Isostearate, Polyglyceryl-4 Isostearate, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Quaternium-18 Bentonite, Dimethicone/Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Triethoxycaprylylsilane, Sodium Chloride, Silica Dimethyl Silylate, PEG/PPG-19/19 Dimethicone, Phellinus Linteus Extract, Cyclotetrasiloxane, Caprylyl Glycol, Butylene Glycol, Portulaca Oleracea Extract, Allantoin, Hydroxyethylcellulose, Ultramarines(CI 77007), Centella Asiatica Extract, Piper Methysticum Leaf/Root/Stem Extract, Adenosine, Caprylhydroxamic Acid, Petrolatum, Tocopheryl Acetate, Mica, Polysilicone-11, Aloe Barbadensis Leaf Juice, Lilium Candidum Bulb Extract, Iris Versicolor Extract, Freesia Alba Flower Extract, Narcissus Pseudo-Narcissus (Daffodil) Flower Extract, Rosa Damascena Flower Water, Leontopodium Alpinum Extract, Nelumbo Nucifera Flower Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warning: 1) For external use only. 2) Consult a dermatologist if the first sign occurs like red spot, swelling, itching, or any allergic reactions. 3) Avoid direct contact with eyes. 4) If contact occurs, flush thoroughly with water. 5) If swallowed, get medical help or contact a Poison Control Center right away. 6) Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Storage and cautions for handling: 1) Keep out of reach of children. 2) Keep away from high or low temperature and direct sunlight.

Description (DESCRIPTION)

Uses: - Ultralight, Multifunctional beauty cream to protect, perfect, tint, and moisturize skin - Features SPF 33 PA+++ sun protection

Directions: Apply moderate amount on entire face after basic skin care.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Titanium Dioxide 8.0%, Ethylhexyl Methoxycinnamate 7.5%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water, Phenyl Trimethicone, Propylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Arbutin, Cyclopentasiloxane, Hexyl Laurate, Cyclohexasiloxane, Methyl Methacrylate Crosspolymer, Iron Oxides (CI 77492), Glycerin, Magnesium Sulfate, Sorbitan Sesquioleate, Zinc stearate, Caprylyl Methicone, Dimethicone, Microcrystalline Wax, Ozokerite, Isostearyl Isostearate, Polyglyceryl-4 Isostearate, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Quaternium-18 Bentonite, Dimethicone/Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Triethoxycaprylylsilane, Sodium Chloride, Silica Dimethyl Silylate, PEG/PPG-19/19 Dimethicone, Phellinus Linteus Extract, Cyclotetrasiloxane, Caprylyl Glycol, Butylene Glycol, Portulaca Oleracea Extract, Allantoin, Hydroxyethylcellulose, Ultramarines(CI 77007), Centella Asiatica Extract, Piper Methysticum Leaf/Root/Stem Extract, Adenosine, Caprylhydroxamic Acid, Petrolatum, Tocopheryl Acetate, Mica, Polysilicone-11, Aloe Barbadensis Leaf Juice, Lilium Candidum Bulb Extract, Iris Versicolor Extract, Freesia Alba Flower Extract, Narcissus Pseudo-Narcissus (Daffodil) Flower Extract, Rosa Damascena Flower Water, Leontopodium Alpinum Extract, Nelumbo Nucifera Flower Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract

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


Advanced Ingredient Data


Raw Label Data

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