3 CONCEPT EYES BACK TO BABY- titanium dioxide, octinoxate cream 
NANDA 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 9.694%, Ethylhexyl Methoxycinnamate 5.000%

INACTIVE INGREDIENT

Inactive ingredients: Water,Cyclopentasiloxane, Butylene Glycol, Phenyl Trimethicone, Dicaprylyl Carbonate, Butylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Zinc Oxide (CI 77947), Niacinamide, Sodium Chloride, Cyclomethicone, Glycerin, Disteardimonium Hectorite, Pentylene Glycol, Iron Oxides (CI 77492), Glyceryl Behenate/Eicosadioate, Sorbitan Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Methyl Methacrylate Crosspolymer, Phenoxyethanol, Dimethicone Crosspolymer, Iron Oxides (CI 77491), Aluminum Hydroxide, Stearic Acid, Iron Oxides (CI 77499), Triethoxycaprylylsilane, Fragrance(Parfum), Acrylates/Dimethicone Copolymer, Dimethicone, Disodium EDTA,Ethylhexylglycerin, Adenosine, Sodium Hyaluronate, Pearl Powder, Amethyst Powder, Tourmaline, Diamond powder, Coral Powder, Portulaca Oleracea Extract, Methylparaben

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:
Keep out of eyes.
Stop use if irritation occurs.
Keep out of reach of babies and children.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children.

INDICATIONS AND USAGE

Indication and usage:
1. Always recap after use.
2. Store this product at room temperature.

DOSAGE AND ADMINISTRATION

Dosage and administration:
Put suitable amount of contents on the sponge or brush and then apply from inside your face evenly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

3 CONCEPT EYES BACK TO BABY 
titanium dioxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.90 mg  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60764-011-0130 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/2013
Labeler - NANDA CO., LTD. (557816075)
Registrant - NANDA CO., LTD. (557816075)
Establishment
NameAddressID/FEIBusiness Operations
NANDA CO., LTD.557816075manufacture(60764-011)

Revised: 2/2014
Document Id: b3aa2f5a-c861-4b79-a873-08f41061efe2
Set id: b556a47a-b1e5-44d0-801c-3660e1212aca
Version: 1
Effective Time: 20140205
 
NANDA CO., LTD.