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

ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL by

Drug Labeling and Warnings

ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL 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 8.84%
Zinc oxide 3.84%

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- 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

Call toll free 1-888-975-2162

Package Labeling:

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10345-913
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	20 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	88.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	38.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
MICA (UNII: V8A1AW0880)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYESTER-10 (UNII: 212N9O2MMZ)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
METHICONE (20 CST) (UNII: 6777U11MKT)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
EUGENOL (UNII: 3T8H1794QW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10345-913-45	1 in 1 BOX	08/21/2018
1		45 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	08/21/2018

Labeler - LABORATOIRES M&L (262533623)