Label: BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 40- octinoxate, titanium dioxide, and zinc oxide liquid
- NDC Code(s): 64141-031-01
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
-
Warnings
For external use only
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>
- PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton
-
INGREDIENTS AND APPEARANCE
BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 40
octinoxate, titanium dioxide, and zinc oxide liquidProduct 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)
