ERBORIAN - CC CREME HIGH DEFINITION SPF 25

ERBORIAN - CC CREME HIGH DEFINITION SPF 25

Drug Labeling and Warnings

Drug Details

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ERBORIAN - CC CREME HIGH DEFINITION SPF 25- octinoxate, octisalate, titanium dioxide, zinc oxide cream 
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 - CC CREME HIGH DEFINITION 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 mesures (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

  • 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 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

  • 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 Dimethicone Crosspolymer - Parfum/Fragrance - Hexyl Cinnamal - Alpha-Isomethyl Ionone - Linalool - Citronellol - Geraniol - Eugenol - Limonene - CI 77491/Iron Oxides

Questions or comments

Call toll free 1-888-975-2162

Product Label

CremeHighDefinition

ERBORIAN - CC CREME HIGH DEFINITION SPF 25 5ml (10345-910-05)

Label

ERBORIAN - CC CREME HIGH DEFINITION SPF 25 
octinoxate, octisalate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem 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)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
MAGNESIUM SULFATE, UNSPECIFIED (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)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
PALMITIC ACID (UNII: 2V16EO95H1)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
GERANIOL (UNII: L837108USY)  
EUGENOL (UNII: 3T8H1794QW)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10345-910-151 in 1 BOX02/06/2015
115 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC: 10345-910-011.5 mL in 1 PACKET; Type 0: Not a Combination Product12/03/2017
3NDC: 10345-910-451 in 1 BOX02/06/2015
345 mL in 1 TUBE; Type 0: Not a Combination Product
4NDC: 10345-910-051 in 1 BOX07/01/2018
45 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/06/2015
Labeler - LABORATOIRES M&L (262533623)

Revised: 12/2018
 
LABORATOIRES M&L


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