INTENSIVE SKIN SERUM FOUNDATION BROAD SPECTRUM SPF 40- octinoxate, titanium dioxide, and zinc oxide lotion 
Bobbi Brown Professional Cosmetics Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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INTENSIVE SKIN SERUM FOUNDATION BROAD SPECTRUM SPF 40

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:

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

Principal Display Panel - 30 ml Tube Carton
INTENSIVE SKIN SERUM FOUNDATION BROAD SPECTRUM SPF 40 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64141-021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.043875 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.068625 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.04275 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64141-021-011 in 1 CARTON12/01/2014
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/01/2014
Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)
Registrant - Estee Lauder Companies Inc. (790802086)
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277MANUFACTURE(64141-021) , REPACK(64141-021) , RELABEL(64141-021)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COMPANY, THE828534516REPACK(64141-021) , RELABEL(64141-021)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.202952982MANUFACTURE(64141-021) , REPACK(64141-021) , RELABEL(64141-021)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.204132062REPACK(64141-021) , RELABEL(64141-021)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326MANUFACTURE(64141-021) , REPACK(64141-021) , RELABEL(64141-021)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC INC943871157REPACK(64141-021) , RELABEL(64141-021)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC PALC102631997REPACK(64141-021) , RELABEL(64141-021)
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152MANUFACTURE(64141-021) , REPACK(64141-021) , RELABEL(64141-021)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774REPACK(64141-021) , RELABEL(64141-021)

Revised: 8/2021
Document Id: b281ecec-558c-482c-a070-dd0865ad41c2
Set id: dcc691f5-e4e8-4559-9c85-1377105b6138
Version: 4
Effective Time: 20210809
 
Bobbi Brown Professional Cosmetics Inc.