BIGGREEN EVERYDAY SUN- titanium dioxide, zinc oxide cream 
BIGGREEN INC.

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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Drug Facts

Titanium Dioxide, Zinc Oxide

Water, Dicaprylyl Carbonate, Polyglyceryl-3 Diisostearate, Glycerin, Polyglyceryl-2 Dipolyhydroxystearate, Stearic Acid, Aluminum Hydroxide, Helianthus Annuus (Sunflower) Seed Oil, Centella Asiatica Extract, Mangifera Indica (Mango) Seed Butter, Cocos Nucifera (Coconut) Oil, Hippophae Rhamnoides Seed Oil, Rosa Canina Fruit Extract, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, Lactobacillus/Hibiscus Sabdariffa FlowerFerment Filtrate, Voacanga Africana Seed Extract, Distarch Phosphate, Sodium Chloride, Glyceryl Caprylate, Silica, 1,2-Hexanediol, Ethyl Ferulate, Hydrolyzed Jojoba Esters, Geranium Maculatum Oil

Skin Protectant - Sun Block

keep out or reach of the children


1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of children

for external use only

label

BIGGREEN EVERYDAY SUN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71251-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE11.25 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.85 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71251-0001-150 g in 1 TUBE; Type 0: Not a Combination Product02/20/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/20/2017
Labeler - BIGGREEN INC. (694492118)
Registrant - BIGGREEN INC. (694492118)
Establishment
NameAddressID/FEIBusiness Operations
Clagen Co., Ltd.690053673manufacture(71251-0001)
Establishment
NameAddressID/FEIBusiness Operations
BIGGREEN INC.694492118label(71251-0001) , pack(71251-0001)

Revised: 5/2018
Document Id: 6cc1a130-c480-0e40-e053-2991aa0a9be8
Set id: 4903b4f0-1e39-66ae-e054-00144ff88e88
Version: 5
Effective Time: 20180521
 
BIGGREEN INC.