FDA.reportPublic FDA data

3 CONCEPT EYES BACK TO BABY

Manufacturer
NANDA CO., LTD.
Effective date
2014-02-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:38:18

Label at a glance#

Product3 CONCEPT EYES BACK TO BABY
Active ingredientTitanium Dioxide, OCTINOXATE
Label structure8 sections

Indications and uses

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Titanium Dioxide 9.694%, Ethylhexyl Methoxycinnamate 5.000%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose: Sunscreen

WARNINGS

WARNINGS SECTION

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

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of babies and children.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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 cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60764-011-012020-01-31C16284748780-19d75b9d0-a23d-f424-e053-dadaa90a57ceb556a47a-b1e5-44d0-801c-3660e1212aca

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60764-011-013 CONCEPT EYES BACK TO BABY30 mL in 1 CARTONCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60764-0113 CONCEPT EYES BACK TO BABY (TITANIUM DIOXIDE, OCTINOXATE) CREAM [NANDA CO., LTD.]1Legacy NDC, 1 package rows20140205_b556a47a-b1e5-44d0-801c-3660e1212aca.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60764-01160764-011-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
OCTINOXATE4Y5P7MUD51ACTIB
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b3aa2f5a-c861-4b79-a873-08f41061efe2b556a47a-b1e5-44d0-801c-3660e1212aca2014-02-05WarningsExact identifier
spl id: b3aa2f5a-c861-4b79-a873-08f41061efe2
spl set id: b556a47a-b1e5-44d0-801c-3660e1212aca

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.