3 CONCEPT EYES BACK TO BABY- titanium dioxide, octinoxate cream

3 CONCEPT EYES BACK TO BABY by

Drug Labeling and Warnings

3 CONCEPT EYES BACK TO BABY by is a Otc medication manufactured, distributed, or labeled by NANDA CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

3 CONCEPT EYES BACK TO BABY 
titanium dioxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60764-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.90 mg  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60764-011-01	30 mL in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2013

Labeler - NANDA CO., LTD. (557816075)

Registrant - NANDA CO., LTD. (557816075)

Establishment
Name	Address	ID/FEI	Business Operations
NANDA CO., LTD.		557816075	manufacture(60764-011)