ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20- octinoxate, titanium dioxide, zinc oxide cream

ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20 by

Drug Labeling and Warnings

ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20 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 Methoxicynnamate / Octinoxate 3%
Titanium dioxide 6,28% 
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 - glycerin - CI 77492/iron oxides - dipropylene glycol - peg-10 dimethicone - dimethicone - isoeicosane - talc - hexyl laurate - betaine - disteardimonium hectorite - panax ginseng root extract - kigelia africana fruit extract - portulaca oleracea extract - lycyrrhiza glabra (licorice) root extract - dioscorea villosa (wild yam) root extract - equisetum giganteum extract - glycosyl trehalose - palmitic acid - magnesium sulfate - aluminum hydroxide - dimethicone/vinyl dimethicone crosspolymer - acrylates/dimethicone copolymer - hydrogenated starch hydrolysate - stearic acid - methicone - phenoxyethanol - tocopheryl acetate - triethoxycaprylylsilane - parfum/fragrance - ethylhexylglycerin
- butylene glycol - hexyl cinnamal - citronellol - alpha-isomethyl ionone - linalool - geraniol - eugenol - limonene - CI 77499/iron oxides - CI 77491/iron oxides

Questions or comments?

Call toll free 1-888-975-2162

Package Labeling:

INGREDIENTS AND APPEARANCE

ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20 
octinoxate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10345-903
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	62.8 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)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOEICOSANE (UNII: AR294KAG3T)
TALC (UNII: 7SEV7J4R1U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
BETAINE (UNII: 3SCV180C9W)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ASIAN GINSENG (UNII: CUQ3A77YXI)
KIGELIA AFRICANA FRUIT (UNII: L4J6XXD1E0)
PURSLANE (UNII: M6S840WXG5)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)
BEMISIOSE (UNII: 76B4LOB2YC)
PALMITIC ACID (UNII: 2V16EO95H1)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
STEARIC ACID (UNII: 4ELV7Z65AP)
METHICONE (20 CST) (UNII: 6777U11MKT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
EUGENOL (UNII: 3T8H1794QW)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10345-903-15	1 in 1 BOX	12/16/2016
1		15 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10345-903-45	1 in 1 BOX	12/16/2016
2		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 final	part352	12/16/2016

Labeler - LABORATOIRES M&L (262533623)

Registrant - LABORATOIRES M&L (262533623)