Label: BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 30- octinoxate, titanium dioxide and zinc oxide liquid
- NDC Code(s): 64141-032-01
- Packager: Bobbi Brown Professional Cosmetics Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 14, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
- Warnings
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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
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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
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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
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 30
octinoxate, titanium dioxide and zinc oxide liquidProduct 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)
