SRB 3 LIGHTING WHITE BB- titanium dioxide, zinc oxide cream 
CASINBIO 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: Titanium Dioxide 10.88%, Zinc Oxide 5.76%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cyclopentasiloxane, Isododecane, Dipropylene Glycol, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, Polymethylsilsesquioxane, Silica, Phenyl Trimethicone, Niacinamide, Sodium Chloride, Iron Oxides (CI 77492), Disteardimonium Hectorite, Methyl Trimethicone, Oryza Sativa (Rice) Bran Extract, Sorbitan Isostearate, Calcium Stearate, Triethoxycaprylylsilane, Triethyl Citrate, Iron Oxides (CI 77491), Hydrogen Dimethicone, Phenoxyethanol, Caprylyl Glycol, Iron Oxides (CI 77499), Fragrance, Dextrin Ethylhexylglycerin, 1,2-Hexanediol, Adenosine, Disodium EDTA, Butylene Glycol, Citrus Aurantifolia (Lime) Flower Extract, Prunus Persica (Peach) Flower Extract, Propylene Glycol, Pyrus Malus (Apple) Flower Extract, Arnica Montana Flower Extract, Ananas sativus (pineapple) fruit Extract, Alchemilla Vulgaris Extract, Actinidia Chinensis (Kiwi) Fruit Extract, Olea Europaea (Olive) Leaf Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Equisetum Arvense Extract, Adansonia Digitata Seed Extract, Punica Granatum Flower Extract, Prunus Avium (Sweet Cherry) Flower Extract, Citrus Aurantium Dulcis (Orange) Flower Extract, Fructan, Sophora Japonica Flower Extract

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: 1. If the following side effects occur, immediately discontinue use. Before resuming use, consult a dermatologist as continual use may worsen symptoms. A) If red spots, swelling, itching, irritation, or other discomforts occur after using the product. B) If the above symptoms occur on the applied area after exposure to direct sunlight. 2. Do not use on open wounds or on areas of skin exhibiting signs of eczema or dermatitis. 3. Storage and handling precautions A) Keep product out of reach of infants and children. B) Ensure that lid is closed after use. C) Do not store in places subject to high or cold temperatures or under exposure to direct sunlight. D) Use care to avoid eye contact when using this product.

DESCRIPTION

How to use: Apply an appropriate amount to areas exposed to sunlight such as the face, neck, arms, legs, and spread evenly.

Recommended dosage: Spread an appropriate amount over areas exposed to sunlight such as the face, neck, arms, and legs

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

SRB 3 LIGHTING WHITE BB 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70218-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide3.80 g  in 35 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.01 g  in 35 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Isododecane (UNII: A8289P68Y2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70218-020-0135 g in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2015
Labeler - CASINBIO CO., LTD. (557830673)
Registrant - CASINBIO CO., LTD. (557830673)
Establishment
NameAddressID/FEIBusiness Operations
CASINBIO CO., LTD.557830673repack(70218-020)
Establishment
NameAddressID/FEIBusiness Operations
Cosmecca Korea Co., Ltd.688830827manufacture(70218-020)

Revised: 11/2015
Document Id: 9d328a75-d0ba-420f-960d-db94c3ce05aa
Set id: 54964164-2794-4192-b9b5-21fa20d12998
Version: 1
Effective Time: 20151112
 
CASINBIO CO., LTD.