ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR- octinoxate, octisalate, titanium dioxide, zinc oxide cream

ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR by

Drug Labeling and Warnings

ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR 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 4.33%

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 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 - Disteardimonium Hectorite - Magnesium Sulfate - Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer - Centella Asiatica Extract - Mel/Honey Extract - Talc - Dimethicone/Vinyl Dimethicone Crosspolymer -Phenoxyethanol - Ethylhexylglycerin - Trihydroxystearin - Butylene Glycol - Mica - Aluminum Hydroxide - Palmitic Acid - Stearic Acid - Polyester- 1 - Silica Dimethyl Silylate - Tocopheryl Acetate - Methicone - Tocopherol - Parfum/Fragrance - Hexyl Cinnamal - Alpha-Isomethyl Ionone - Linalool - Citronellol - Geraniol - Eugenol - Limonene - Cl 77492/Iron Oxides - Cl77491/Iron Oxides - Cl77499/Iron Oxides

Questions or comments?

Call toll free 1-888-975-2162

Package Labeling:

ERBORIAN - CC CREME HIGH DEFINITION SPF 25 CLAIR 5ml (

10345-911-05)

INGREDIENTS AND APPEARANCE

ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR 
octinoxate, octisalate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10345-911
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	43.3 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)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
TALC (UNII: 7SEV7J4R1U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYESTER-10 (UNII: 212N9O2MMZ)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10345-911-15	1 in 1 BOX	07/13/2016
1		15 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10345-911-01	1.5 mL in 1 PACKET; Type 0: Not a Combination Product	12/03/2017
3	NDC: 10345-911-45	1 in 1 BOX	07/13/2016
3		45 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 10345-911-05	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	07/13/2016

Labeler - LABORATOIRES M&L (262533623)