SPL v1
SPL
SPL Set ID 565cc2fb-8b1c-4fb3-a4f7-6af3656e5d4d
Route
TOPICAL
Published
Effective Date 2013-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Snail, Unspecified (18.05 g) Titanium Dioxide (3.6 g) Zinc Oxide (2.52 g) Arbutin (0.8 g) Adenosine (0.016 g)
Inactive Ingredients
Phenyl Trimethicone Dimethicone Butylene Glycol Dicaprylate/dicaprate Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Butylene Glycol Cyclomethicone 5 Cyclomethicone 6 Magnesium Sulfate Trimethylsiloxysilicate (m/q 0.6-0.8) Aluminum Hydroxide Stearic Acid Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Brown Iron Oxide Quaternium-18 Bentonite Caprylyl Glycol .alpha.-tocopherol Acetate Edetate Disodium 1,2-hexanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-03-01

Description

Active ingredients: Snail Secretion Filtrate 45.12%, Titanium Dioxide 9.01%, Zinc Oxide 6.30%, Arbutin 2%, Adenosine 0.04%


Medication Information

Description

Active ingredients: Snail Secretion Filtrate 45.12%, Titanium Dioxide 9.01%, Zinc Oxide 6.30%, Arbutin 2%, Adenosine 0.04%

Section 51727-6

Inactive Ingredients:Phenyl Trimethicone, Dimethicone, Butylene Glycol Dicaprylate/Dicaprate, Orbignya Oleifera Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Magnesium Sulfate, Trimethylsiloxysilicate, , Aluminum Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Fragrance, Iron Oxide, Quaternium-18, Bentonite, Caprylyl Glycol, Tocopherol Acetate, Disodium EDTA

Section 51945-4

Section 55105-1

Purpose: Skin Protectant

Section 55106-9

Active ingredients: Snail Secretion Filtrate 45.12%, Titanium Dioxide 9.01%, Zinc Oxide 6.30%, Arbutin 2%, Adenosine 0.04%


Structured Label Content

Section 51727-6 (51727-6)

Inactive Ingredients:Phenyl Trimethicone, Dimethicone, Butylene Glycol Dicaprylate/Dicaprate, Orbignya Oleifera Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Magnesium Sulfate, Trimethylsiloxysilicate, , Aluminum Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Fragrance, Iron Oxide, Quaternium-18, Bentonite, Caprylyl Glycol, Tocopherol Acetate, Disodium EDTA

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Skin Protectant

Section 55106-9 (55106-9)

Active ingredients: Snail Secretion Filtrate 45.12%, Titanium Dioxide 9.01%, Zinc Oxide 6.30%, Arbutin 2%, Adenosine 0.04%


Advanced Ingredient Data


Raw Label Data

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