TOUCH IN SOL DARK LONG LASTING PRIMER BASE PURE PEACH- octinoxate, zinc oxide, titanium dioxide cream
BONNE CO.,LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Active Ingredient: Ethylhexyl Methoxycinnamate 5%, Zinc Oxide 4.9%, Titanium Dioxide 2.0916%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cyclopentasiloxane, Diphenylsiloxy Phenyl Trimethicone, Cyclohexasiloxane, Butylene Glycol, PEG-10 Dimethicone, Glycerin, Niacinamide, Dicaprylyl Carbonate, Methyl Methacrylate Crosspolymer, Disteardimonium Hectorite, Dimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Polysilicone-11, Magnesium Sulfate, Phenoxyethanol, Dimethicone Crosspolymer, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Tribehenin, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Stearic Acid, Ultramarines (CI 77007), Trimethylsiloxysilicate, Fragrance(Parfum), Copernicia Cerifera (Carnauba) Wax, Ethylhexylglycerin, Adenosine, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Disodium EDTA, Triethoxycaprylylsilane, Hypoxis Rooperi Rhizome Extract, Caesalpinia Spinosa Gum, Sodium Benzoate, Potassium Sorbate

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Keep out of reach of children.

DESCRIPTION

Uses: Apply all over or spot treat as desired. Pat gently to absorb.

Directions: For sunscreen use: Apply liberally and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

TOUCH IN SOL DARK LONG LASTING PRIMER BASE PURE PEACH
octinoxate, zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69997-080
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	1.25 g in 25 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.22 g in 25 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.52 g in 25 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69997-080-02	1 in 1 CARTON	12/20/2016	06/29/2018
1	NDC:69997-080-01	25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/20/2016	06/29/2018

Labeler - BONNE CO.,LTD (557821750)

Registrant - BONNE CO.,LTD (557821750)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmax, Inc.		689049693	manufacture(69997-080)

Revised: 7/2018

Document Id: 6c3bce14-88d8-4db9-ae57-0793b5697763

Set id: c99d2a6a-9890-4bca-a1df-5f65d5d04475

Version: 2

Effective Time: 20180710

BONNE CO.,LTD