LONG WEAR GET OVER BB- titanium dioxide, zinc oxide cream 
1004LABORATORY

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.

----------

ACTIVE INGREDIENT

Active Ingredient: Titanium Dioxide 11.25%, Zinc Oxide 4.90%

INACTIVE INGREDIENT

Inactive Ingredients: Glycyrrhiza Glabra (Licorice) Root Water, Camellia Sinensis Leaf Water, Aloe Barbadensis Leaf Water, Coco-Caprylate/Caprate, Dicaprylyl Carbonate, Polyglyceryl-3 Diisostearate, Glycerin, Isoamyl Laurate, Polyglyceryl-2 Dipolyhydroxyste arate, Sodium Chloride, Calen dula Officinalis Flower Extract, Sorbitan Olivate, NelumboNu cifera Flower Water, Centaurea Cyanus Flower Water, Lacto bacillus/Hibiscus Sabdariffa Flower Ferment Filtrate, Rosa Centifolia Flower Water, Zant hoxylum Piperitum Fruit Ext ract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, Cocos Nucifera (Coco nut) Oil, Hippophae Rham no ides Seed Oil, Voacanga Afri cana Seed Extract, Rosa Cani na Fruit Extract, Yellow Oxide of Iron, alpha-bisabolol, Water, Morus Alba Bark Extract, Saccharomyces/Caragana Sinica Root Ferment Extract, Glycine Max (Soybean) Seed Extract, Chamomilla Recutita (Ma tricaria) Flower/Leaf Extract, Rosmarinus Officinalis (Rosemary) Extract, Lavandula Angustifolia (Lavender) Extract, Monarda Didyma Leaf Extract, Ocimum Basilicum (Basil) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Origanum Vulg are Leaf Extract, Mentha Viri dis (Spearmint) Extract, Melissa Officinalis Extract, Ethyl Ferulate, Oenothera Biennis (Evening Primrose) Oil, Borago Officinalis Seed Oil, Pistacia Vera Seed Oil, Red Oxide of Iron, Glyceryl Caprylate, Aluminum Hydroxide, stearic Acid, Citrus Aurantium Dulcis (Orange) Oil, Glycyrrhiza Glabra (Licorice) Root Extract, Rhodiola Rosea Root Extract, Rosa Damascena Flower Extract, Taraxacum Offi cinale (Dandelion) Leaf Extract, Olea Europaea (Olive) Leaf Extract, Mangifera Indica (Mango) Seed Butter, Argania Spinosa Kernel Oil, Black Oxide of Iron, Lavandula Angustifolia(Lavender) Oil, Adenosine

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: 1. Stop using the product if the following problems arise while using the product as continued use could worsen the symptoms; consult with a dermatologist. A. If red spots, swelling, itchiness, and irritation occur. B. If the above problems occur on the applied area on the skin from direct sunlight 2. Do not use on areas with wounds, eczema, and dermatitis. 3. Storage and handling precautions A. Close the lid after use. B. Keep away from the reach of babies and children. C. Do not store in high-temperature or low-temperature and keep away from direct sunlight 4. Wash off the product if it gets in the eye

DESCRIPTION

Indications & Usage: After washing the face, dispense an appropriate amount into your palm, and evenly apply to the entire face.

Dosage & Administration: Use the eyedropper to pump 1~2times.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

LONG WEAR GET OVER BB 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69739-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide3.37 mg  in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.47 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Licorice (UNII: 61ZBX54883)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69739-020-0130 mL in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2015
Labeler - 1004LABORATORY (689512629)
Registrant - 1004LABORATORY (689512629)
Establishment
NameAddressID/FEIBusiness Operations
1004LABORATORY689512629manufacture(69739-020)

Revised: 4/2015
Document Id: 8f5d8bb6-0b80-4416-be12-44517001e965
Set id: ac3da3c6-9be6-4eac-8b8d-6b56c8db9ca4
Version: 2
Effective Time: 20150424
 
1004LABORATORY