FDA.reportPublic FDA data

ERBORIAN - BB CREME NUDE SPF20

Manufacturer
LABORATOIRES M&L
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:04:34

Label at a glance#

ProductERBORIAN - BB CREME NUDE SPF20
Active ingredientOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure7 sections

Indications and uses

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

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: -Limit time in the sun, especiall...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 3.00% 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 Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

-For external use only. Do not use on damaged or broken skin

-When using this product keep out of eyes. Rinse with water to remove

-Stop use and ask a doctor if 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: -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






Sun Protection Measures

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua/water - cyclomethicone- glycerin hexyl laurate - dipropylene glycol - peg-10 dimethicone- talc - dimethicone- isoeicosane-disteardimonium hectorite - betaine -centella asiatica extract- polygonum cuspidatum root extract - scutellaria baicalensis root extract - camellia sinensis leaf extract - glycyrrhiza glabra (licorice) root extract - chamomilla recutita (matricaria) flower extract - portulaca oleracea extract - rosmarinus officinalis (rosemary) leaf extract - hydrogenated starch hydrolysate - ethylhexylglycerin - tocopheryl acetate - magnesium sulfate - silica - glycosyl trehalose - aluminum hydroxide - palmitic acid - stearic acid - butylene glycol - phenoxyethanol - vinyl dimethicone/methicone silsesquioxane crosspolymer - acrylates/dimethicone copolymer - dimethicone/vinyl dimethicone crosspolymer -methicone - CI 77492/iron oxides - CI 77499/iron oxides - CI 77491/iron oxides

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
10345-902-15ERBORIAN - BB CREME NUDE SPF2015 mL in 1 TUBECREAM156
10345-902-15ERBORIAN - BB CREME NUDE SPF201 in 1 BOXCREAM16
10345-902-45ERBORIAN - BB CREME NUDE SPF201 in 1 BOXCREAM16
10345-902-45ERBORIAN - BB CREME NUDE SPF2045 mL in 1 TUBECREAM456

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10345-902ERBORIAN - BB CREME NUDE SPF20 (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]6Current NDC, Legacy NDC, 4 package rows20231216_337a771e-c965-421a-a8e7-d853ffe51c2c.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10345-90210345-902-45, 10345-902-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CYCLOMETHICONENMQ347994ZIACT
DIPROPYLENE GLYCOLE107L85C40IACT
TALC7SEV7J4R1UIACT
DIMETHICONE92RU3N3Y1OIACT
ISOEICOSANEAR294KAG3TIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
BETAINE3SCV180C9WIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
HYDROGENATED STARCH HYDROLYSATE27F77DSJ5VIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
PALMITIC ACID2V16EO95H1IACT
STEARIC ACID4ELV7Z65APIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

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 NUDE SPF20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L337a771e-c965-421a-a8e7-d853ffe51c2c2023-12-15WarningsExact identifier
ndc (package): 10345-902-15
ndc (package): 10345-902-45
ndc (product): 10345-902
ndc11 (package): 10345090245
ndc11 (package): 10345090215
spl id: 0c99ba55-77d2-f62d-e063-6394a90a60c1
spl set id: 337a771e-c965-421a-a8e7-d853ffe51c2c

Reported adverse events (FAERS/openFDA)#

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