TONYMOLY LUMINOUS GODDESS AURA BB 02- titanium dioxide, octinoxate, zinc oxide cream 
Tonymoly 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 9.94%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 2.94%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cyclopentasiloxane, Dipropylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Phenyl Trimethicone, Cyclohexasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Arbutin, Hexyldecyl Myristoyl Methylaminopropionate, Hexyl Laurate, Iron Oxides (CI 77492), Sorbitan Sesquioleate, Magnesium Sulfate, Phenoxyethanol, Disteardimonium Hectorite, Isoamyl p-Methoxycinnamate, Silica, Iron Oxides (CI 77491), Tribehenin, Iron Oxides (CI 77499), Aluminum Hydroxide, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Stearic Acid, Triethoxycaprylylsilane, Glyceryl Behenate, Calcium Stearate, Polyglyceryl-6 Octastearate, Fragrance(Parfum), Ethylhexylglycerin, Dimethicone, Disodium EDTA, Adenosine, Water, Butylene Glycol, Ceramide 3, Tremella Fuciformis (Mushroom) Extract, Mica (CI 77019), Glycerin, Melissa Officinalis Leaf Extract, Malva Sylvestris (Mallow) Extract, Achillea Millefolium Extract, Alchemilla Vulgaris Extract, Primula Veris Extract, Mentha Piperita (Peppermint) Leaf Extract, Veronica Officinalis Extract, Ethyl Hexanediol, Oxygen

PURPOSE

Purpose: Sunscreen

WARNINGS

Warning: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of Children: Keep out of reach of babies and children

INDICATIONS & USAGE

Indication & Usage: After application of skin care products, apply on face using fingertips or sponge.

DOSAGE & ADMINISTRATION

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

Image of carton

TONYMOLY LUMINOUS GODDESS AURA BB  02
titanium dioxide, octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide4.47 g  in 45 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.15 g  in 45 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.32 g  in 45 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dipropylene Glycol (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-052-0145 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2014
Labeler - Tonymoly Co., Ltd. (688216798)
Registrant - Tonymoly Co., Ltd. (688216798)
Establishment
NameAddressID/FEIBusiness Operations
Tonymoly Co., Ltd.688216798repack(59078-052)
Establishment
NameAddressID/FEIBusiness Operations
COSMAX INC.689019313manufacture(59078-052)

Revised: 3/2015
Document Id: 8220f498-5457-4241-8dd2-1aa3c1733e68
Set id: bd99a8f7-6300-4d6d-b3ab-f301b3278e16
Version: 1
Effective Time: 20150303
 
Tonymoly Co., Ltd.