INTENSIVE SKIN SERUM FOUNDATION BROAD SPECTRUM SPF 40- octinoxate, titanium dioxide, and zinc oxide lotion

INTENSIVE SKIN SERUM FOUNDATION BROAD SPECTRUM SPF 40 by

Drug Labeling and Warnings

INTENSIVE SKIN SERUM FOUNDATION BROAD SPECTRUM SPF 40 by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate 3.9%

Titanium Dioxide 6.1%

Zinc Oxide 3.8%

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 dimethicone octyldodecyl neopentanoate butyloctyl salicylate isononyl isononanoate methyl trimethicone butylene glycol diethylhexyl succinate lauryl peg-9 polydimethylsiloxyethyl dimethicone laureth-4 cetyl peg/ppg-10/1 dimethicone magnesium sulfate dipentaerythrityl tri-polyhydroxystearate citrullus vulgaris (watermelon) fruit extract laminaria saccharina extract litchi chinensis seed extract lens esculenta (lentil) fruit extract artemia extract cordyceps sinensis extract pyrus malus (apple) fruit extract lavandula angustifolia (laven der) oil sasa veitchii extract thermus thermophillus ferment dimethicone silylate sodium lactate acetyl hexapeptide-8 tocopheryl acetate glycerin hydrolyzed wheat protein/pvp crosspolymer caprylyl glycol sodium pca methicone dimethicone/peg-10/15 crosspolymer triethoxycaprylylsilane dimethicone crosspolymer-3 sodium hyaluronate potassium sorbate dipropylene glycol dextrin silica disodium edta linalool phenoxyethanol [+/- mica titanium dioxide (ci 77891) iron oxides (ci 77492) iron oxides (ci 77491) iron oxides (ci 77499)] <41438>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

BOBBI
BROWN

Intensive Skin Serum
Foundation
Broad Spectrum SPF 40

Lychee, Bamboo Grass &
Cordyceps Extracts

1 FL. OZ./30 ml e

INGREDIENTS AND APPEARANCE

INTENSIVE SKIN SERUM FOUNDATION BROAD SPECTRUM SPF 40 
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.043875 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.068625 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.04275 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
octyldodecyl neopentanoate (UNII: X8725R883T)
butyloctyl salicylate (UNII: 2EH13UN8D3)
isononyl isononanoate (UNII: S4V5BS6GCX)
methyl trimethicone (UNII: S73ZQI0GXM)
butylene glycol (UNII: 3XUS85K0RA)
diethylhexyl succinate (UNII: 69W9UMG3P8)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
laureth-4 (UNII: 6HQ855798J)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
watermelon (UNII: 231473QB6R)
saccharina latissima (UNII: 68CMP2MB55)
litchi chinensis seed (UNII: 9294024N9Q)
lens culinaris fruit (UNII: ZYZ076G9JH)
ophiocordyceps sinensis (UNII: 8Q1GYP08KU)
apple (UNII: B423VGH5S9)
lavender oil (UNII: ZBP1YXW0H8)
thermus thermophilus lysate (UNII: 775R692494)
sodium lactate (UNII: TU7HW0W0QT)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
glycerin (UNII: PDC6A3C0OX)
caprylyl glycol (UNII: 00YIU5438U)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
triethoxycaprylylsilane (UNII: LDC331P08E)
hyaluronate sodium (UNII: YSE9PPT4TH)
potassium sorbate (UNII: 1VPU26JZZ4)
dipropylene glycol (UNII: E107L85C40)
icodextrin (UNII: 2NX48Z0A9G)
silicon dioxide (UNII: ETJ7Z6XBU4)
edetate disodium (UNII: 7FLD91C86K)
linalool, (+/-)- (UNII: D81QY6I88E)
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: 64141-021-01	1 in 1 CARTON	12/01/2014
1		30 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	12/01/2014

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(64141-021) , REPACK(64141-021)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(64141-021)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(64141-021)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(64141-021)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(64141-021)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(64141-021) , REPACK(64141-021)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(64141-021) , REPACK(64141-021)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(64141-021)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(64141-021)