ERBORIAN - BB CREME NUDE SPF20- octinoxate, titanium dioxide, zinc oxide cream

ERBORIAN - BB CREME NUDE SPF20 by

Drug Labeling and Warnings

ERBORIAN - BB CREME NUDE SPF20 by is a Otc medication manufactured, distributed, or labeled by LABORATOIRES M&L. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 3.00%
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

Inactive Ingredients

Aqua/water - cyclomethicone- glycerin hexyl laurate - dipropylene glycol - peg-10 dimethicone- talc - dimethicone- isoeicosane-disteardimonium hectorite - betaine -centella asiatica extract- polygonum cuspidatum root extract - scutellaria baicalensis root extract - camellia sinensis leaf extract - glycyrrhiza glabra (licorice) root extract - chamomilla recutita (matricaria) flower extract - portulaca oleracea extract - rosmarinus officinalis (rosemary) leaf extract - hydrogenated starch hydrolysate - ethylhexylglycerin - tocopheryl acetate - magnesium sulfate - silica - glycosyl trehalose - aluminum hydroxide - palmitic acid - stearic acid - butylene glycol - phenoxyethanol - vinyl dimethicone/methicone silsesquioxane crosspolymer - acrylates/dimethicone copolymer - dimethicone/vinyl dimethicone crosspolymer -methicone - CI 77492/iron oxides - CI 77499/iron oxides - CI 77491/iron oxides

Package Labeling:

INGREDIENTS AND APPEARANCE

ERBORIAN - BB CREME NUDE SPF20 
octinoxate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10345-902
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)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOEICOSANE (UNII: AR294KAG3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BETAINE (UNII: 3SCV180C9W)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10345-902-45	1 in 1 BOX	08/17/2016
1		45 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10345-902-15	1 in 1 BOX	08/17/2016
2		15 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	08/17/2016

Labeler - LABORATOIRES M&L (262533623)