BOBBI BROWN SKIN FOUNDATION BROAD SPECTRUM SPF 15- octinoxate and titanium dioxide liquid

BOBBI BROWN SKIN FOUNDATION by

Drug Labeling and Warnings

BOBBI BROWN SKIN FOUNDATION by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., JO COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate 7.50%
Titanium Dioxide 1.00%

Purpose

Sunscreen

Use

Helps prevent sunburn

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 product is 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 two 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

water\aqua\eau methyl trimethicone neopentyl glycol diethylhexanoate isononyl isononanoate glycerin pentylene glycol lauryl peg-9 polydimethylsiloxyethyl dimethicone hdi/trimethylol hexyllactone crosspolymer talc boron nitride disteardimonium hectorite stearic acid palmitic acid dimethicone lecithin aluminum dimyristate tocopherol myristic acid silica magnesium ascorbyl phosphate sodium chloride sodium citrate sorbic acid chlorphenesin phenoxyethanol [+/- titanium dioxide (ci 77891) iron oxides (ci 77491, ci 77492, ci 77499)] <iln34969>

Other information

Protect the product in this container from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Dist. Bobbi Brown Professional Cosmetics
N.Y., N.Y. 10022

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

BOBBI
BROWN

Skin Foundation
Broad Spectrum SPF 15

1 FL. OZ./ 30 ml e

INGREDIENTS AND APPEARANCE

BOBBI BROWN SKIN FOUNDATION   BROAD SPECTRUM SPF 15
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.078 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.0104 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
methyl trimethicone (UNII: S73ZQI0GXM)
neopentyl glycol diethylhexanoate (UNII: U68ZV6W62C)
isononyl isononanoate (UNII: S4V5BS6GCX)
glycerin (UNII: PDC6A3C0OX)
pentylene glycol (UNII: 50C1307PZG)
talc (UNII: 7SEV7J4R1U)
boron nitride (UNII: 2U4T60A6YD)
stearic acid (UNII: 4ELV7Z65AP)
palmitic acid (UNII: 2V16EO95H1)
dimethicone (UNII: 92RU3N3Y1O)
aluminum dimyristate (UNII: J2KA067N9O)
tocopherol (UNII: R0ZB2556P8)
myristic acid (UNII: 0I3V7S25AW)
silicon dioxide (UNII: ETJ7Z6XBU4)
magnesium ascorbyl phosphate (UNII: 0R822556M5)
sodium chloride (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
sorbic acid (UNII: X045WJ989B)
chlorphenesin (UNII: I670DAL4SZ)
phenoxyethanol (UNII: HIE492ZZ3T)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-013-01	1 in 1 CARTON	09/01/2012
1		30 mL in 1 BOTTLE; 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	09/01/2012

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Establishment
Name	Address	ID/FEI	Business Operations
JO COSMETICS		691485222	MANUFACTURE(64141-013)

Establishment
Name	Address	ID/FEI	Business Operations
JO COSMETICS		691704652	MANUFACTURE(64141-013)

Establishment
Name	Address	ID/FEI	Business Operations
JO COSMETICS		711029256	MANUFACTURE(64141-013)