FDA.reportPublic FDA data

ERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 25

Manufacturer
LABORATOIRES M&L
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 00:52:05

Label at a glance#

ProductERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 25
Active ingredientOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure15 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 SunProtectionMeasures. Spending time in the sun increases your riskofskincancerandearlyskinaging. Todecreasethisrisk, 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, espe...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethylhexyl methoxycinnamate / Octinoxate 6.00%

Ethylhexyl salicylate / Octisalate 2.00%

Titanium dioxide 4.97%

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

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

  1. 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
  • SunProtectionMeasures. Spending time in the sun increases your riskofskincancerandearlyskinaging. Todecreasethisrisk, 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

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 - dipropylene glycol - glycerin - peg-10 dimethicone - methyl trimethicone - C12-15 alkyl benzoate - dimethicone - CI 77492/iron oxides - disteardimonium hectorite - magnesium sulfate - vinyl dimethicone /methicone silsesquioxane crosspolymer - centella asiatica extract - mel/honey extract - mica - talc - trihydroxystearin - butylene glycol - polyester-1 - aluminum hydroxide - silica dimethyl silylate - palmitic acid - stearic acid - tocopheryl acetate - ethylhexylglycerin - phenoxyethanol - methicone - dimethicone/vinyl imethicone crosspolymer - parfum/fragrance - hexyl cinnamal - alpha-isomethyl ionone - linalool - citronellol - geraniol - eugenol - limonene - CI 77491/iron oxides - CI 77499/iron oxides

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-975-2162

​Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethylhexyl methoxycinnamate / Octinoxte 6.00%

Ethylhexyl salicylate / Octisalate 2.00%

Titanium Dioxide 4.33%

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 andearly skin aging caused by the sun

​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
  • Sun Protection Meausres.  Spending time in the sun incerases 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.

​Other information

SPL UNCLASSIFIED SECTION

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

​Inactive ingredients

INACTIVE INGREDIENT SECTION

qua/water - cyclomethicone - dipropylene glycol - glycerin - peg-10 dimethicone - methyl trimethicone - C12-15 alkyl benzoate - dimethicone - disteardimonium hectorite - magnesium sulfate - vinyl dimethicone/methicone silsesquiocane crosspolymer - centella asiatica extract - mel/honey extract - talc - dimethicone/vinyl dimethicone crosspolymer - phenoxyethanol - ethylhexylglycerin - trihydroxystearn - butylene glycol - mica - aluminum hydroxide - palmitic acid - stearicacid - polyester-1 - silica dimethyl silyate - tocopheryl acetate - methicone - tocopherol - parfum/fragrance - hexyl cinnamal - alpha-isomethyl ionone - linalool - citronellol - geraniol - eugenol - limonene - CI 77492/iron oxides - CI 77491/Iron oxides - CI77499/iron oxides

​Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-975-2162

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122

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
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
10345-910-01ERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 251.5 mL in 1 PACKETCREAM1.5 mL60 mg in 1mL12
10345-911-01ERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 251.5 mL in 1 PACKETCREAM1.5 mL60 mg in 1mL12
10345-921-01ERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 251 in 1 KITKIT112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10345-910ERBORIAN DOUBLE SAMPLE CC CREME CLAIR AND DORE SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) KIT [LABORATOIRES M&L]12Current NDC, Legacy NDC20250112_41b3cf18-dc11-4e1d-802e-5ba25bd87adb.zip
10345-911ERBORIAN DOUBLE SAMPLE CC CREME CLAIR AND DORE SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) KIT [LABORATOIRES M&L]12Current NDC, Legacy NDC20250112_41b3cf18-dc11-4e1d-802e-5ba25bd87adb.zip
10345-921ERBORIAN DOUBLE SAMPLE CC CREME CLAIR AND DORE SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) KIT [LABORATOIRES M&L]12Current NDC, Legacy NDC, 3 package rows20250112_41b3cf18-dc11-4e1d-802e-5ba25bd87adb.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10345-92110345-921-01
10345-91110345-911-01
10345-91010345-910-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 69 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
CENTELLA ASIATICA7M867G6T1UIACT
HONEYY9H1V576FHIACT
MICAV8A1AW0880IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
PALMITIC ACID2V16EO95H1IACT
STEARIC ACID4ELV7Z65APIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
METHICONE (20 CST)6777U11MKTIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
LINALOOL, (+/-)-D81QY6I88EIACT
WATER059QF0KO0RIACT
CYCLOMETHICONENMQ347994ZIACT
DIPROPYLENE GLYCOLE107L85C40IACT
GLYCERINPDC6A3C0OXIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIMETHICONE92RU3N3Y1OIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
GERANIOLL837108USYIACT
EUGENOL3T8H1794QWIACT
LIMONENE, (+)-GFD7C86Q1WIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
CYCLOMETHICONENMQ347994ZIACT
DIPROPYLENE GLYCOLE107L85C40IACT
GLYCERINPDC6A3C0OXIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIMETHICONE92RU3N3Y1OIACT

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L41b3cf18-dc11-4e1d-802e-5ba25bd87adb2025-01-09WarningsExact identifier
ndc (package): 10345-910-01
ndc (package): 10345-921-01
ndc (package): 10345-911-01
ndc (product): 10345-921
ndc11 (package): 10345091101
ndc11 (package): 10345091001
ndc11 (package): 10345092101
spl id: 2b4a4d54-89a4-74e7-e063-6294a90a49f9
spl set id: 41b3cf18-dc11-4e1d-802e-5ba25bd87adb
ERBORIAN - CC CREME HIGH DEFINITION SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L3421b9a3-6551-406f-af3a-b3da8a01d2b22024-12-11WarningsExact identifier
ndc (package): 10345-910-01
ndc (product): 10345-910
ndc11 (package): 10345091001
ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lb55be8cb-7f21-45b0-bb8f-a60182077ca32024-12-11WarningsExact identifier
ndc (package): 10345-911-01
ndc (product): 10345-911
ndc11 (package): 10345091101

Reported adverse events (FAERS/openFDA)#

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