BOBBI BROWN TINTED MOISTURIZER 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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BOBBI BROWN TINTED MOISTURIZER BROAD SPECTRUM SPF 15

Drug Facts

Active Ingredients

Octinoxate 7.50%

Titanium Dioxide 3.00%

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 • phenyl trimethicone • butylene glycol • pentaerythrityl tetraoctanoate • simmondsia chinensis (jojoba) seed oil • petrolatum • biosaccharide gum - 1 • steareth-21 • glyceryl stearate • sodium hyaluronate • tocopheryl acetate • polymethyl methacrylate • magnesium aluminum silicate • ethylhexylglycerin • caprylyl glycol • cetyl alcohol • acrylamide/sodium acryloyldimethyltaurate copolymer • peg-12 dimethicone • isohexadecane • lecithin • xanthan gum • steareth-2 • potassium stearate • citric acid • fragrance (parfum) • limonene • linalool • benzyl salicylate • polysorbate 80 • disodium edta • phenoxyethanol • sorbic acid • [+/- titanium dioxide (ci 77891) • iron oxides (ci 77491, ci 77492, ci 77499)] <iln33789>

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

SPF 15

Tinted

Moisturizer

Broad

Spectrum

SPF 15

BOBBI BROWN

1.7 FL. OZ./50 ml e

Principal Display Panel

BOBBI BROWN TINTED MOISTURIZER BROAD SPECTRUM SPF 15 
octinoxate and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64141-027
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
JOJOBA OIL (UNII: 724GKU717M)  
PETROLATUM (UNII: 4T6H12BN9U)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
STEARETH-21 (UNII: 53J3F32P58)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STEARETH-2 (UNII: V56DFE46J5)  
POTASSIUM STEARATE (UNII: 17V812XK50)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SORBIC ACID (UNII: X045WJ989B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64141-027-011 in 1 CARTON01/01/200105/01/2025
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02001/01/2001
Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)
Registrant - Estee Lauder Companies Inc. (790802086)
Establishment
NameAddressID/FEIBusiness Operations
PALC078364654pack(64141-027) , label(64141-027)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.204132062pack(64141-027) , label(64141-027) , manufacture(64141-027)
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture(64141-027) , pack(64141-027) , label(64141-027)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326manufacture(64141-027) , pack(64141-027) , label(64141-027)
Establishment
NameAddressID/FEIBusiness Operations
The Estee Lauder Inc802599436manufacture(64141-027) , pack(64141-027) , label(64141-027)
Establishment
NameAddressID/FEIBusiness Operations
Northtec LLC943871157pack(64141-027) , label(64141-027)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774pack(64141-027) , label(64141-027)

Revised: 4/2023
Document Id: fa58da35-2e26-99e7-e053-6394a90a6643
Set id: 7c8d3d8f-2ba0-40df-a972-51c9269f210b
Version: 7
Effective Time: 20230427
 
Bobbi Brown Professional Cosmetics Inc.