FDA.reportPublic FDA data

ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL

Manufacturer
LABORATOIRES M&L
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:42:27

Label at a glance#

ProductERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL
Active ingredientOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection mesures (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 Sun Protection Measures. 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 t...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethylhexyl methoxycinnamate / Octinoxate 6.00%
Ethylhexyl salicylate / Octisalate 2.00%
Titanium dioxide 8.84%
Zinc oxide 3.84%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection mesures (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

  • 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 Measures. 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

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

AQUA/WATER- CYCLOPENTASILOXANE - CI 77492/IRON OXIDES - DIPROPYLENE GLYCOL - GLYCERIN - PEG-10 DIMETHICONE - METHYL TRIMETHICONE - METHYL TRIMETHICONE - MICA - C12-15 ALKYL BENZOATE - DIMETHICONE - CI 77491/IRON OXIDES - MAGNESIUM SULFATE - VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER - DISTEARDIMONIUM HECTORITE - POLYESTER-1 - SILICA DIMETHYL SILYLATE - CENTELLA ASIATICA EXTRACT - TALC - DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER - ALUMINUM HYDROXIDE - PHENOXYETHANOL - TRIHYDROXYSTEARIN - BUTYLENE GLYCOL - METHICONE - PALMITIC ACID - STEARIC ACID - TOCOPHERYL ACETATE - ETHYLHEXYLGLYCERIN - CI 77499/ IRON OXIDES - PARFUM/FRAGRANCE - HEXYL CINNAMAL - ALPHA-ISOMETHYLIONONE-LINALOOL - CITRONELLOL - GERANIOL - EUGENOL - LIMONENE

Questions or comments

OTC - QUESTIONS SECTION

Call toll free 1-888-975-2162

Package Labeling: 10345-913-05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling: 10345-913-45

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4545

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
10345-913-05ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL1 in 1 BOXCREAM17
10345-913-05ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL5 mL in 1 TUBECREAM57
10345-913-45ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL1 in 1 BOXCREAM17
10345-913-45ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL45 mL in 1 TUBECREAM457

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10345-913ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]7Current NDC, Legacy NDC, 4 package rows20241213_70a5537c-a364-4dae-8ab2-8ca0cbfd11b7.zip

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10345-91310345-913-45, 10345-913-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
FERRIC OXIDE RED1K09F3G675IACT
CYCLOMETHICONE 50THT5PCI0RIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
DIPROPYLENE GLYCOLE107L85C40IACT
GLYCERINPDC6A3C0OXIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
METHYL TRIMETHICONES73ZQI0GXMIACT
MICAV8A1AW0880IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIMETHICONE92RU3N3Y1OIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
POLYESTER-10212N9O2MMZIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
CENTELLA ASIATICA7M867G6T1UIACT
TALC7SEV7J4R1UIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRIHYDROXYSTEARIN06YD7896S3IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
METHICONE (20 CST)6777U11MKTIACT
PALMITIC ACID2V16EO95H1IACT
STEARIC ACID4ELV7Z65APIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
LINALOOL, (+/-)-D81QY6I88EIACT
EUGENOL3T8H1794QWIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
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 CC CREME HIGH DEFINITION SPF 25 CARAMELOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L70a5537c-a364-4dae-8ab2-8ca0cbfd11b72024-12-11WarningsExact identifier
ndc (package): 10345-913-05
ndc (package): 10345-913-45
ndc (product): 10345-913
ndc11 (package): 10345091345
ndc11 (package): 10345091305
spl id: 28fdfd84-8898-2162-e063-6294a90a075b
spl set id: 70a5537c-a364-4dae-8ab2-8ca0cbfd11b7

Reported adverse events (FAERS/openFDA)#

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