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 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
SunProtectionMeasures. Spending time in the sun increases your riskofskincancerandearlyskinaging. Todecreasethisrisk, 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 imethicone crosspolymer - parfum/fragrance - hexyl cinnamal - alpha-isomethyl ionone - linalool - citronellol - geraniol - eugenol - limonene - CI 77491/iron oxides - CI 77499/iron oxides

Questions or comments?

Call toll free 1-888-975-2162

Drug Facts

Active ingredients

Ethylhexyl methoxycinnamate / Octinoxte 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 andearly 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 Meausres. Spending time in the sun incerases 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

qua/water - cyclomethicone - dipropylene glycol - glycerin - peg-10 dimethicone - methyl trimethicone - C12-15 alkyl benzoate - dimethicone - disteardimonium hectorite - magnesium sulfate - vinyl dimethicone/methicone silsesquiocane crosspolymer - centella asiatica extract - mel/honey extract - talc - dimethicone/vinyl dimethicone crosspolymer - phenoxyethanol - ethylhexylglycerin - trihydroxystearn - butylene glycol - mica - aluminum hydroxide - palmitic acid - stearicacid - polyester-1 - silica dimethyl silyate - tocopheryl acetate - methicone - tocopherol - parfum/fragrance - hexyl cinnamal - alpha-isomethyl ionone - linalool - citronellol - geraniol - eugenol - limonene - CI 77492/iron oxides - CI 77491/Iron oxides - CI77499/iron oxides

Questions or comments?

Call toll free 1-888-975-2162

Package Labeling:

ERBORIAN DOUBLE SAMPLE CC CREME CLAIR AND DORE SPF 25
octinoxate, octisalate, titanium dioxide, zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10345-921

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10345-921-01	1 in 1 KIT	12/03/2017

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 PACKET	1.5 mL
Part 2	1 PACKET	1.5 mL

Part 1 of 2

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

Product Information
Item Code (Source)	NDC:10345-911
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	43.3 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	19.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
HONEY (UNII: Y9H1V576FH)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
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)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
.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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10345-911-01	1.5 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	12/03/2017

Part 2 of 2

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MAGNESIUM SULFATE, UNSPECIFIED FORM (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)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHICONE (20 CST) (UNII: 6777U11MKT)
.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)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10345-910-01	1.5 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	12/03/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	12/03/2017

Labeler - LABORATOIRES M&L (262533623)

ERBORIAN - DOUBLE SAMPLE CC CREME CLAIR & DORE SPF 25

Drug Facts

Active ingredients

Purpose

Uses

Warnings

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Questions or comments?

​Drug Facts

​Active ingredients

​Purpose

​Uses

​Warnings

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

​Directions

​Other information

​Inactive ingredients

​Questions or comments?

Package Labeling:

Drug Facts

Active ingredients

Purpose

Uses

Warnings

Directions

Other information

Inactive ingredients

Questions or comments?