Label: ERBORIAN DOUBLE SAMPLE CC CREME CLAIR AND DORE SPF 25- octinoxate, octisalate, titanium dioxide, zinc oxide kit
- NDC Code(s): 10345-910-01, 10345-911-01, 10345-921-01
- Packager: LABORATOIRES M&L
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 15, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Uses
- Warnings
-
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
-
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?
- Drug Facts
- Active ingredients
- Uses
- Warnings
-
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
-
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?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
ERBORIAN DOUBLE SAMPLE CC CREME CLAIR AND DORE SPF 25
octinoxate, octisalate, titanium dioxide, zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10345-921 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10345-921-01 1 in 1 KIT 12/03/2017 Quantity of Parts Part # Package Quantity Total Product Quantity 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 creamProduct Information Item Code (Source) NDC:10345-911 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 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 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10345-911-01 1.5 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 12/03/2017 Part 2 of 2 ERBORIAN - CC CREME HIGH DEFINITION SPF 25
octinoxate, octisalate, titanium dioxide, zinc oxide creamProduct Information 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) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10345-910-01 1.5 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 12/03/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 12/03/2017 Labeler - LABORATOIRES M&L (262533623)
