FDA.reportPublic FDA data

ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20

Manufacturer
LABORATOIRES M&L
Effective date
2023-12-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:04:34

Label at a glance#

ProductERBORIAN - BB CREME AU GINSENG CARAMEL SPF20
Active ingredientOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see  ), decreases the risk of skin cancer and early skin aging caused by the sun Directions

Dosage and administration

For sunscreen use: Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures. Limit time in t...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethylhexyl Methoxicynnamate / Octinoxate 3% Titanium dioxide 6,28%  Zinc oxide 1.92%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see  ), decreases the risk of skin cancer and early skin aging caused by the sun Directions

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • Limit time in the sun, especially from 10 a.m. –2 p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses
  • Children under 6 months of age: Ask a doctor 

Other information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua/water - cyclomethicone - glycerin - CI 77492/iron oxides - dipropylene glycol - peg-10 dimethicone - dimethicone - isoeicosane - talc - hexyl laurate - betaine - disteardimonium hectorite - panax ginseng root extract - kigelia africana fruit extract - portulaca oleracea extract - lycyrrhiza glabra (licorice) root extract - dioscorea villosa (wild yam) root extract - equisetum giganteum extract - glycosyl trehalose - palmitic acid - magnesium sulfate - aluminum hydroxide - dimethicone/vinyl dimethicone crosspolymer - acrylates/dimethicone copolymer - hydrogenated starch hydrolysate - stearic acid - methicone - phenoxyethanol - tocopheryl acetate - triethoxycaprylylsilane - parfum/fragrance - ethylhexylglycerin - butylene glycol - hexyl cinnamal - citronellol - alpha-isomethyl ionone - linalool - geraniol - eugenol - limonene - CI 77499/iron oxides - CI 77491/iron oxides

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-975-2162

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
10345-903-15ERBORIAN - BB CREME AU GINSENG CARAMEL SPF201 in 1 BOXCREAM14
10345-903-15ERBORIAN - BB CREME AU GINSENG CARAMEL SPF2015 mL in 1 TUBECREAM154
10345-903-45ERBORIAN - BB CREME AU GINSENG CARAMEL SPF2045 mL in 1 TUBECREAM454
10345-903-45ERBORIAN - BB CREME AU GINSENG CARAMEL SPF201 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10345-903ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]4Current NDC, Legacy NDC, 4 package rows20231216_43c81760-6bb6-25fe-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10345-90310345-903-15, 10345-903-45

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CYCLOMETHICONENMQ347994ZIACT
GLYCERINPDC6A3C0OXIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
DIPROPYLENE GLYCOLE107L85C40IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
DIMETHICONE92RU3N3Y1OIACT
ISOEICOSANEAR294KAG3TIACT
TALC7SEV7J4R1UIACT
HEXYL LAURATE4CG9F9W01QIACT
BETAINE3SCV180C9WIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ASIAN GINSENGCUQ3A77YXIIACT
KIGELIA AFRICANA FRUITL4J6XXD1E0IACT
PURSLANEM6S840WXG5IACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
DIOSCOREA VILLOSA TUBERIWY3IWX2G8IACT
BEMISIOSE76B4LOB2YCIACT
PALMITIC ACID2V16EO95H1IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
HYDROGENATED STARCH HYDROLYSATE27F77DSJ5VIACT
STEARIC ACID4ELV7Z65APIACT
METHICONE (20 CST)6777U11MKTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
LINALOOL, (+/-)-D81QY6I88EIACT
GERANIOLL837108USYIACT
EUGENOL3T8H1794QWIACT
LIMONENE, (+)-GFD7C86Q1WIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE RED1K09F3G675IACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML

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
ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L43c81760-6bb6-25fe-e054-00144ff8d46c2023-12-09WarningsExact identifier
ndc (package): 10345-903-45
ndc (package): 10345-903-15
ndc (product): 10345-903
ndc11 (package): 10345090345
ndc11 (package): 10345090315
spl id: 0c1069d3-14b3-9959-e063-6294a90a7d85
spl set id: 43c81760-6bb6-25fe-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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