BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 30- octinoxate, titanium dioxide and zinc oxide liquid

BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 30 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 6.7%
Titanium Dioxide 2.1%
Zinc Oxide 1.3%

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 octyldodecyl neopentanoate dimethicone butyloctyl salicylate diethylhexyl succinate butylene glycol cetyl peg/ppg-10/1 dimethicone methyl trimethicone lauryl peg-9 polydimethylsiloxyethyl dimethicone laureth-4 isononyl isononanoate tocopheryl acetate sodium hyaluronate laminaria saccharina extract citrullus lanatus (watermelon) fruit extract ganoderma lucidum (mushroom) extract pyrus malus (apple) fruit extract cordyceps sinensis extract lens esculenta (lentil) fruit extract litchi chinensis seed extract sapindus mukorossi fruit extract sasa kurilensis water polygonum cuspidatum root extract hippophae rhamnoides extract panax ginseng (ginseng) root extract lavandula angustifolia (lavender) oil glycerin methicone hydrolyzed wheat protein/pvp crosspolymer sodium pca sodium lactate dimethicone crosspolymer-3 dimethicone/vinyl dimethicone crosspolymer thermus thermophillus ferment caesalpinia spinosa gum magnesium sulfate aluminum hydroxide dimethicone/peg-10/15 crosspolymer caprylyl glycol dipropylene glycol dipentaerythrityl tri-polyhydroxystearate dextrin 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)] <iln48153>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

BOBBI
BROWN

Intensive
SERUM FOUNDATION

Broad Spectrum
SPF 30

1 FL. OZ./30 ml ℮

INGREDIENTS AND APPEARANCE

BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 30 
octinoxate, titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	67 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	21 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
LAURETH-4 (UNII: 6HQ855798J)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
WATERMELON (UNII: 231473QB6R)
REISHI (UNII: TKD8LH0X2Z)
APPLE (UNII: B423VGH5S9)
OPHIOCORDYCEPS SINENSIS (UNII: 8Q1GYP08KU)
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
LITCHI CHINENSIS SEED (UNII: 9294024N9Q)
SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)
SASA KURILENSIS WHOLE (UNII: X399JB9XAS)
REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)
LAVENDER OIL (UNII: ZBP1YXW0H8)
GLYCERIN (UNII: PDC6A3C0OX)
METHICONE (20 CST) (UNII: 6777U11MKT)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SODIUM LACTATE (UNII: TU7HW0W0QT)
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 RESIN (UNII: WL3883U2PO)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
STEARIC ACID (UNII: 4ELV7Z65AP)
LINALOOL, (+)- (UNII: F4VNO44C09)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISODIUM ZINC EDETATE (UNII: R84OV391BA)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-032-01	1 in 1 CARTON	04/12/2021
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	04/12/2021

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(64141-032)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		204132062	pack(64141-032) , label(64141-032)