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

ERBORIAN - CC CREME HIGH DEFINITION SPF 25 by

Drug Labeling and Warnings

ERBORIAN - CC CREME HIGH DEFINITION SPF 25 by is a Otc medication manufactured, distributed, or labeled by LABORATOIRES M&L. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

ERBORIAN - CC CREME HIGH DEFINITION SPF 25 5ml (

10345-910-05)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10345-910
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	20 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	49.7 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	19.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10345-910-15	1 in 1 BOX	02/06/2015
1		15 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10345-910-01	1.5 mL in 1 PACKET; Type 0: Not a Combination Product	12/03/2017
3	NDC: 10345-910-45	1 in 1 BOX	02/06/2015
3		45 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 10345-910-05	1 in 1 BOX	07/01/2018
4		5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/06/2015

Labeler - LABORATOIRES M&L (262533623)