SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15- octinoxate and titanium dioxide 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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SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15

Drug Facts

Active Ingredients

Octinoxate 3.0%
Titanium Dioxide 1.6%

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 suncreen use:

Inactive ingredients

water\aqua\eau • dimethicone • trimethylsiloxysilicate • cetyl peg/ppg-10/1 dimethicone • butylene glycol • glycerin • disteardimonium hectorite • polyglyceryl-3 diisostearate • sodium chloride • laminaria saccharina extract • butyrospermum parkii (shea butter) • fragrance (parfum) • ascorbyl palmitate • tocopherol • dimethicone crosspolymer • methicone • stearic acid • tocopheryl acetate • glyceryl oleate • lecithin • glyceryl stearate • citric acid • aluminum hydroxide • talc • disodium edta • linalool • sodium dehydroacetate • phenoxyethanol • [+/- mica • titanium dioxide (ci 77891) • iron oxides (ci 77492) • iron oxides (ci 77491) • iron oxides (ci 77499)] <iln44078>

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

BOBBI
BROWN

Skin Long-Wear Weightless
Foundation
Broad Spectrum SPF 15

Full Cover
Oil-Free Shine Control

1 FL. OZ./30 ml e

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15 
octinoxate and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64141-025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE30 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE16 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
SHEA BUTTER (UNII: K49155WL9Y)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
TOCOPHEROL (UNII: R0ZB2556P8)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
TALC (UNII: 7SEV7J4R1U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
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:64141-025-011 in 1 CARTON07/21/2017
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:64141-025-021 in 1 CARTON12/22/2022
213 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02007/21/2017
Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)
Registrant - Estee Lauder Companies Inc. (790802086)
Establishment
NameAddressID/FEIBusiness Operations
PALC078364654pack(64141-025) , label(64141-025)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.204132062pack(64141-025) , label(64141-025)
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture(64141-025) , pack(64141-025) , label(64141-025)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326manufacture(64141-025) , pack(64141-025) , label(64141-025)
Establishment
NameAddressID/FEIBusiness Operations
The Estee Lauder Inc802599436manufacture(64141-025) , pack(64141-025) , label(64141-025)
Establishment
NameAddressID/FEIBusiness Operations
Northtec LLC943871157pack(64141-025) , label(64141-025)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774pack(64141-025) , label(64141-025)

Revised: 1/2023
Document Id: f0708711-a932-563f-e053-2995a90a276c
Set id: b669c36d-4c94-455d-8534-9c3bb024d668
Version: 8
Effective Time: 20230109
 
Bobbi Brown Professional Cosmetics Inc.