Label: BIGGREEN EVERYDAY SUN- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71251-0001-1 - Packager: BIGGREEN INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 21, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
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
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
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 - DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIGGREEN EVERYDAY SUN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71251-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 11.25 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4.85 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71251-0001-1 50 g in 1 TUBE; Type 0: Not a Combination Product 02/20/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/20/2017 Labeler - BIGGREEN INC. (694492118) Registrant - BIGGREEN INC. (694492118) Establishment Name Address ID/FEI Business Operations Clagen Co., Ltd. 690053673 manufacture(71251-0001) Establishment Name Address ID/FEI Business Operations BIGGREEN INC. 694492118 label(71251-0001) , pack(71251-0001)
