PERFECT SEBUM CONTROL REAL FOUNDATION 23 NATURAL BEIGE- titanium dioxide, octinoxate, zinc oxide 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 ingredients: Titanium Dioxide 9.168%, Ethylhexyl Methoxycinnamate 4.0%, Zinc Oxide 2.6754%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Butylene Glycol, Neopentyl Glycol Diethylhexanoate, Trimethylsiloxysilicate, Butylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Methyl Trimethicone, Sodium Chloride, CI 77492, Phenyl Trimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Methyl Methacrylate Crosspolymer, Phenoxyethanol, Stearic Acid, Dimethicone, Disteardimonium Hectorite, Silica, Sorbitan Isostearate, CI 77491, Boron Nitride, Palmitic Acid, Triethoxycaprylylsilane, Aluminum Hydroxide, Cyclohexasiloxane, CI 77499, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Fragrance, Ethylhexylglycerin, Disodium EDTA, Copernicia Cerifera (Carnauba) Wax, Ficus Carica (Fig) Fruit Extract, Punica Granatum Fruit Extract, Morus Alba Fruit Extract, Ginkgo Biloba Nut Extract, Euterpe Oleracea Fruit Extract, Caprylyl Glycol, Glycerin, Caprylhydroxamic Acid

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. Rinse with water to remove

- Stop use and ask a doctor if rash occurs

- Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

DESCRIPTION

Uses:

Use helps prevent sunburn


Directions:

For sunscreen use - apply liberally and evenly 15 minutes before sun exposure

- reapply at least every two hours

- Sun protection measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including.

- children under 6 months of age : ask doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

PERFECT SEBUM CONTROL REAL FOUNDATION 23 NATURAL BEIGE 
titanium dioxide, octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69997-210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.75 g  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.20 g  in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.80 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69997-210-021 in 1 CARTON02/01/201806/29/2018
1NDC:69997-210-0130 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/201806/29/2018
Labeler - BONNE CO.,LTD (557821750)
Registrant - BONNE CO.,LTD (557821750)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(69997-210)

Revised: 7/2018
 
BONNE CO.,LTD