ERBORIAN - DOUBLE SAMPLE CC CREME CLAIR & DORE SPF 25

ERBORIAN - DOUBLE SAMPLE CC CREME CLAIR & DORE SPF 25

Drug Labeling and Warnings

Drug Details

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ERBORIAN DOUBLE SAMPLE CC CREME CLAIR AND DORE SPF 25- octinoxate, octisalate, titanium dioxide, zinc oxide 
LABORATOIRES M&L

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ERBORIAN - DOUBLE SAMPLE CC CREME CLAIR & DORE SPF 25

Drug Facts

Active ingredients

Ethylhexyl methoxycinnamate / Octinoxate 6.00%

Ethylhexyl salicylate / Octisalate 2.00%

Titanium dioxide 4.97%

Zinc oxide 1.92%

Purpose

Sunscreen

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

Warnings

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

  1. rash occurs.

Keep out of reach of children.

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

Directions

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

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

Inactive ingredients

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?

Call toll free 1-888-975-2162

​Drug Facts

​Active ingredients

Ethylhexyl methoxycinnamate / Octinoxte 6.00%

Ethylhexyl salicylate / Octisalate 2.00%

Titanium Dioxide 4.33%

Zinc oxide 1.92%

​Purpose

Sunscreen

​Uses

  • 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

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.

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

​Directions

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

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

​Inactive ingredients

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?

Call toll free 1-888-975-2162

Package Labeling:

ClairLabel1ClairLabel2CC Creme LabelCombinedLabels

ERBORIAN DOUBLE SAMPLE CC CREME CLAIR AND DORE SPF 25 
octinoxate, octisalate, titanium dioxide, zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10345-921
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10345-921-011 in 1 KIT12/03/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 1.5 mL
Part 21 PACKET 1.5 mL
Part 1 of 2
ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR 
octinoxate, octisalate, titanium dioxide, zinc oxide cream
Product Information
Item Code (Source)NDC: 10345-911
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE43.3 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION19.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
HONEY (UNII: Y9H1V576FH)  
MICA (UNII: V8A1AW0880)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
PALMITIC ACID (UNII: 2V16EO95H1)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
GERANIOL (UNII: L837108USY)  
EUGENOL (UNII: 3T8H1794QW)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10345-911-011.5 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart352
Part 2 of 2
ERBORIAN - CC CREME HIGH DEFINITION SPF 25 
octinoxate, octisalate, titanium dioxide, zinc oxide cream
Product Information
Item Code (Source)NDC: 10345-910
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE60 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE20 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE49.7 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION19.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
HONEY (UNII: Y9H1V576FH)  
MICA (UNII: V8A1AW0880)  
TALC (UNII: 7SEV7J4R1U)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
PALMITIC ACID (UNII: 2V16EO95H1)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
GERANIOL (UNII: L837108USY)  
EUGENOL (UNII: 3T8H1794QW)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10345-910-011.5 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart352
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/03/2017
Labeler - LABORATOIRES M&L (262533623)

Revised: 12/2018
 
LABORATOIRES M&L


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