BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 40- octinoxate, titanium dioxide, and zinc oxide liquid

BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 40 by

Drug Labeling and Warnings

BOBBI BROWN INTENSIVE 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 4.0%
Titanium Dioxide 6.2%
Zinc Oxide 3.9%

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 and evenly 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 methyl trimethicone isononyl isononanoate butylene glycol diethylhexyl succinate lauryl peg-9 polydimethylsiloxyethyl dimethicone cetyl peg/ppg-10/1 dimethicone laureth-4 tocopheryl acetate sodium hyaluronate citrullus lanatus (watermelon) fruit extract litchi chinensis seed extract sapindus mukorossi fruit extract laminaria saccharina extract lens esculenta (lentil) fruit extract polygonum cuspidatum root extract hippophae rhamnoides extract ganoderma lucidum (mushroom) extract pyrus malus (apple) fruit extract panax ginseng (ginseng) root extract cordyceps sinensis extract lavandula angustifolia (lavender) oil sasa kurilensis water glycerin methicone sodium pca sodium lactate hydrolyzed wheat protein/ pvp crosspolymer dimethicone crosspolymer-3 dimethicone/vinyl dimethicone crosspolymer thermus thermophillus ferment caesalpinia spinosa gum magnesium sulfate aluminum hydroxide dextrin dimethicone/peg-10/15 crosspolymer caprylyl glycol dipropylene glycol dipentaerythrityl tri-polyhydroxystearate stearic acid linalool bht disodium edta sodium citrate phenoxyethanol potassium sorbate sodium benzoate [+/- mica titanium dioxide (ci 77891) iron oxides (ci 77491) iron oxides (ci 77492) iron oxides (ci 77499)] <iln48151>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

BOBBI
BROWN

Intensive
SERUM FOUNDATION

Broad Spectrum
SPF 40

1 FL. OZ./30 ml e

INGREDIENTS AND APPEARANCE

BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 40 
octinoxate, titanium dioxide, and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	62 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	39 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SASA KURILENSIS WHOLE (UNII: X399JB9XAS)
GLYCERIN (UNII: PDC6A3C0OX)
METHICONE (20 CST) (UNII: 6777U11MKT)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SODIUM LACTATE (UNII: TU7HW0W0QT)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
THERMUS THERMOPHILUS (UNII: 415H64SACF)
CAESALPINIA SPINOSA WHOLE (UNII: O759MFY23D)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)
STEARIC ACID (UNII: 4ELV7Z65AP)
LINALOOL OXIDE (UNII: 4UJJ55KMCS)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
LAURETH-4 (UNII: 6HQ855798J)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
WATERMELON (UNII: 231473QB6R)
LITCHI CHINENSIS SEED (UNII: 9294024N9Q)
SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
REISHI (UNII: TKD8LH0X2Z)
APPLE (UNII: B423VGH5S9)
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)
OPHIOCORDYCEPS SINENSIS (UNII: 8Q1GYP08KU)
LAVENDER OIL (UNII: ZBP1YXW0H8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-031-01	1 in 1 CARTON	01/27/2021
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	01/27/2021

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		202952982	manufacture(64141-031)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		204132062	pack(64141-031) , label(64141-031)