BOBBIE BROWN CORRECTIVE SPOT TREATMENT BROAD SPECTRUM SPF 25- octinoxate and titanium dioxide cream

BOBBIE BROWN CORRECTIVE SPOT TREATMENT BROAD SPECTRUM by

Drug Labeling and Warnings

BOBBIE BROWN CORRECTIVE SPOT TREATMENT BROAD SPECTRUM by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., ELGC K.K., Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), Estee Lauder 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, Pennsylvania Logistics Center, NIPPON SHIKAZAI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Octinoxate 7.00%
Titanium Dioxide 1.10%

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

isododecane talc trimethylsiloxysilicate polyethylene alumina diphenylsiloxy phenyl trimethicone disteardimonium hectorite microcrystalline wax\cera microcristallina\cire microcristalline ascorbyl glucoside morus nigra (mulberry) root extract hydrolyzed rice bran extract scutellaria baicalensis root extract vitis vinifera (grape) fruit extract gentiana lutea (gentian) root extract cholesterol stearyl glycyrrhetinate sucrose dimethicone propylene carbonate sorbitan sesquiisostearate linoleic acid butylene glycol aluminum hydroxide methicone tocopherol water\aqua\eau phenoxyethanol [+/- mica iron oxides (ci 77492) iron oxides (ci 77491) iron oxides (ci 77499) titanium dioxide (ci 77891)] <iln39231>

Other information

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 4.5 ML Tube Carton

BOBBI BROWN

CORRECTIVE SPOT TREATMENT
BROAD SPECTRUM SPF 25

4.5 ML / .15 FL. OZ.

INGREDIENTS AND APPEARANCE

BOBBIE BROWN CORRECTIVE SPOT TREATMENT BROAD SPECTRUM   SPF 25
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	98 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	15.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
isododecane (UNII: A8289P68Y2)
talc (UNII: 7SEV7J4R1U)
high density polyethylene (UNII: UG00KM4WR7)
aluminum oxide (UNII: LMI26O6933)
diphenylsiloxy phenyl trimethicone (UNII: I445L28B12)
microcrystalline wax (UNII: XOF597Q3KY)
ascorbyl glucoside (UNII: 2V52R0NHXW)
morus nigra root (UNII: 033456LFG1)
scutellaria baicalensis root (UNII: 7J95K7ID2S)
wine grape (UNII: 3GOV20705G)
gentiana lutea root (UNII: S72O3284MS)
cholesterol (UNII: 97C5T2UQ7J)
stearyl glycyrrhetinate (UNII: 3YYE6VJS0P)
sucrose (UNII: C151H8M554)
dimethicone (UNII: 92RU3N3Y1O)
propylene carbonate (UNII: 8D08K3S51E)
linoleic acid (UNII: 9KJL21T0QJ)
butylene glycol (UNII: 3XUS85K0RA)
aluminum hydroxide (UNII: 5QB0T2IUN0)
tocopherol (UNII: R0ZB2556P8)
water (UNII: 059QF0KO0R)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
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: 64141-113-01	1 in 1 CARTON
1		4.5 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/10/2012

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(64141-113) , REPACK(64141-113)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(64141-113) , RELABEL(64141-113) , REPACK(64141-113)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc.		042918826	MANUFACTURE(64141-113)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(64141-113) , RELABEL(64141-113)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(64141-113)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(64141-113)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(64141-113)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(64141-113)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(64141-113)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(64141-113) , RELABEL(64141-113) , REPACK(64141-113)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(64141-113) , RELABEL(64141-113) , REPACK(64141-113)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(64141-113) , RELABEL(64141-113) , REPACK(64141-113)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(64141-113)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(64141-113)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(64141-113) , RELABEL(64141-113)

Establishment
Name	Address	ID/FEI	Business Operations
NIPPON SHIKAZAI		692572936	MANUFACTURE(64141-113)