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: 10345-913-05

Label

Package Labeling: 10345-913-45

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
FERRIC OXIDE RED (UNII: 1K09F3G675)
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10345-913-45	1 in 1 BOX	08/21/2018
1		45 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:10345-913-05	1 in 1 BOX	04/16/2021
2		5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	08/21/2018

Labeler - LABORATOIRES M&L (262533623)

ERBORIAN - CC CREME HIGH DEFINITION SPF 25 CARAMEL