FDA.reportPublic FDA data

ERBORIAN - BB CREME AU GINSENG DORE SPF 20

Product NDC
10345-901
11-digit product format
103450901
Labeler code
10345
Product ID
10345-901_28fdebae-dc06-098a-e063-6394a90a7644
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
LABORATOIRES M&L
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-02-06
Substance
OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
30; 62.8; 19.2 mg/mL; mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ERBORIAN - BB CREME AU GINSENG DORE SPF 20
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE30 mg/mL
TITANIUM DIOXIDE62.8 mg/mL
ZINC OXIDE19.2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Y5P7MUD51, 15FIX9V2JP, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10345-901-15ERBORIAN - BB CREME AU GINSENG DORE SPF 201 in 1 BOXCREAM18
10345-901-15ERBORIAN - BB CREME AU GINSENG DORE SPF 2015 mL in 1 TUBECREAM158
10345-901-45ERBORIAN - BB CREME AU GINSENG DORE SPF 2045 mL in 1 TUBECREAM458
10345-901-45ERBORIAN - BB CREME AU GINSENG DORE SPF 201 in 1 BOXCREAM18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51ERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51ERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
ZINC CATIONACTIVE MOIETY13S1S8SF37ERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
.ALPHA.-HEXYLCINNAMALDEHYDEINACTIVE INGREDIENT7X6O37OK2IERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
.BETA.-CITRONELLOL, (R)-INACTIVE INGREDIENTP01OUT964KERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0ERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
ASIAN GINSENGINACTIVE INGREDIENTCUQ3A77YXIERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
BETAINEINACTIVE INGREDIENT3SCV180C9WERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
DIOSCOREA VILLOSA TUBERINACTIVE INGREDIENTIWY3IWX2G8ERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40ERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
DISTEARDIMONIUM HECTORITEINACTIVE INGREDIENTX687XDK09LERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
EUGENOLINACTIVE INGREDIENT3T8H1794QWERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
GERANIOLINACTIVE INGREDIENTL837108USYERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
HEXYL LAURATEINACTIVE INGREDIENT4CG9F9W01QERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
ISOEICOSANEINACTIVE INGREDIENTAR294KAG3TERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
ISOMETHYL-.ALPHA.-IONONEINACTIVE INGREDIENT9XP4LC555BERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
KIGELIA AFRICANA FRUITINACTIVE INGREDIENTL4J6XXD1E0ERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
LICORICEINACTIVE INGREDIENT61ZBX54883ERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88EERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SABERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1ERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
PURSLANEINACTIVE INGREDIENTM6S840WXG5ERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
WATERINACTIVE INGREDIENT059QF0KO0RERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10345-901ERBORIAN - BB CREME AU GINSENG DORE SPF 20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]8Current NDC, Legacy NDC, 4 package rows20241213_121aa873-5ca6-426b-8ece-dcb5a9f82a03.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10345-901-15103450901151 TUBE in 1 BOX (10345-901-15) / 15 mL in 1 TUBE1 tube2015-02-060000-00-00NoNoCurrent
10345-901-45103450901451 TUBE in 1 BOX (10345-901-45) / 45 mL in 1 TUBE1 tube2015-02-060000-00-00NoNoCurrent