LONG-WEAR EVEN FINISH FOUNDATION BROAD SPECTRUM SPF 15- octinoxate and titanium dioxide liquid

LONG-WEAR EVEN FINISH FOUNDATION BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

LONG-WEAR EVEN FINISH FOUNDATION BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., ELGC Kabushiki Kaisha, Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ARAMIS, INC, ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate 2.90%
Titanium Dioxide 1.60%

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 dimethicone cetyl peg/ppg-10/1 dimethicone butylene glycol glycerin trimethylsiloxysilicate sodium chloride polyglyceryl-3 diisostearate disteardimonium hectorite butyrospermum parkii (shea butter) lavandula angustifolia (lavender) glyceryl oleate lecithin methicone dimethicone crosspolymer tocopheryl acetate tocopherol ascorbyl palmitate glyceryl stearate alumina stearic acid citric acid talc disodium edta linalool sodium dehydroacetate phenoxyethanol [+/- titanium dioxide (ci 77891) mica iron oxides (ci 77491, ci 77492, ci 77499)]<iln38637>

Other information

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

SPL UNCLASSIFIED SECTION

Dist. Bobbie Brown Professional Cosmetics
N.Y., N.Y. 10022 London W1K 3BQ Paris

PRINCIPAL DISPLAY PANEL - 30 ml Carton

BOBBI
BROWN

Long-Wear
Even Finish Foundation
Broad Spectrum SPF 15

1 FL. OZ./30 ml e

INGREDIENTS AND APPEARANCE

LONG-WEAR EVEN FINISH FOUNDATION BROAD SPECTRUM SPF 15 
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.9 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.6 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
butylene glycol (UNII: 3XUS85K0RA)
glycerin (UNII: PDC6A3C0OX)
sodium chloride (UNII: 451W47IQ8X)
shea butter (UNII: K49155WL9Y)
lavandula angustifolia flower (UNII: 19AH1RAF4M)
glyceryl monooleate (UNII: 4PC054V79P)
alpha-tocopherol acetate (UNII: 9E8X80D2L0)
tocopherol (UNII: R0ZB2556P8)
ascorbyl palmitate (UNII: QN83US2B0N)
glyceryl monostearate (UNII: 230OU9XXE4)
aluminum oxide (UNII: LMI26O6933)
stearic acid (UNII: 4ELV7Z65AP)
citric acid monohydrate (UNII: 2968PHW8QP)
talc (UNII: 7SEV7J4R1U)
edetate disodium (UNII: 7FLD91C86K)
linalool, (+/-)- (UNII: D81QY6I88E)
sodium dehydroacetate (UNII: 8W46YN971G)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
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: 64141-011-01	1 in 1 CARTON
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2011

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC Kabushiki Kaisha		712808195	RELABEL(64141-011) , REPACK(64141-011)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(64141-011) , RELABEL(64141-011) , REPACK(64141-011)

Establishment
Name	Address	ID/FEI	Business Operations
ARAMIS, INC		042918826	MANUFACTURE(64141-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(64141-011) , RELABEL(64141-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(64141-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(64141-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(64141-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(64141-011)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(64141-011)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		787336577	MANUFACTURE(64141-011) , RELABEL(64141-011) , REPACK(64141-011)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		949264774	MANUFACTURE(64141-011) , RELABEL(64141-011) , REPACK(64141-011)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		618107429	MANUFACTURE(64141-011) , RELABEL(64141-011) , REPACK(64141-011)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(64141-011)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(64141-011)