FDA.reportPublic FDA data

3LAB PERFECT BB SPF 40 Broad Spectrum 02

Product NDC
76159-002
11-digit product format
761590002
Labeler code
76159
Product ID
76159-002_0c5bb478-7c63-4a3d-e063-6294a90a1000
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
3LAB, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-10
Substance
TITANIUM DIOXIDE
Active strength
121.6 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
3LAB PERFECT BB SPF 40 Broad Spectrum 02
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE121.6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76159-002-003LAB PERFECT BB SPF 40 Broad Spectrum 0245 mL in 1 TUBECREAM457
76159-002-003LAB PERFECT BB SPF 40 Broad Spectrum 021 in 1 CARTONCREAM17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L03LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
ACHILLEA MILLEFOLIUMINACTIVE INGREDIENT2FXJ6SW4PK3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
ADENOSINEINACTIVE INGREDIENTK72T3FS5673LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90M3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
ALLANTOININACTIVE INGREDIENT344S277G0Z3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69333LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
ALUMINUM STARCH OCTENYLSUCCINATEINACTIVE INGREDIENTI9PJ0O62943LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
ASCORBYL GLUCOSIDEINACTIVE INGREDIENT2V52R0NHXW3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
BORON NITRIDEINACTIVE INGREDIENT2U4T60A6YD3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
CAPRYLYL TRISILOXANEINACTIVE INGREDIENTQ95M2P1KJL3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
CERAMIDE 3INACTIVE INGREDIENT4370DF050B3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C403LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV03LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
FENNEL SEEDINACTIVE INGREDIENTG3QC02NIE63LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6753LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3573LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
GLYCERETH-26INACTIVE INGREDIENTNNE56F2N143LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FX3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
HOPSINACTIVE INGREDIENT01G73H6H833LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
MELISSA OFFICINALIS LEAFINACTIVE INGREDIENT50D2ZE92193LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
NEOPENTYL GLYCOL DICAPRATEINACTIVE INGREDIENT77T908SE823LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
ORANGE OILINACTIVE INGREDIENTAKN3KSD11B3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
PEG/PPG-18/18 DIMETHICONEINACTIVE INGREDIENT9H0AO7T7943LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
PEG/PPG-20/15 DIMETHICONEINACTIVE INGREDIENT06R6X77P9C3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4R3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4T3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU43LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
SODIUM OLEATEINACTIVE INGREDIENT399SL044HN3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY373LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A23LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
SQUALANEINACTIVE INGREDIENTGW89575KF93LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P83LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
UREAINACTIVE INGREDIENT8W8T17847W3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
VISCUM ALBUM FRUITING TOPINACTIVE INGREDIENTBK9092J5MP3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
WATERINACTIVE INGREDIENT059QF0KO0R3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE3LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76159-0023LAB PERFECT BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC]7Current NDC, Legacy NDC, 2 package rows20231213_bf4419b9-408d-469a-aa15-bbf419632f02.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76159-002-00761590002001 TUBE in 1 CARTON (76159-002-00) / 45 mL in 1 TUBE1 tube2017-12-190000-00-00NoNoCurrent