Label: BOBBI BROWN CC BROAD SPECTRUM SPF 25- octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 64141-018-01 - Packager: Bobbi Brown Professional Cosmetics Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 August 12, 2021
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
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Directions
For sunscreen use:
- apply liberally 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 • dimethicone • butylene glycol • phenyl trimethicone • pentylene glycol • glyceryl stearate • behenyl alcohol • trioctyldodecyl citrate • polymethylsilsesquioxane • octyldodecyl stearoyl stearate • peg-40 stearate • polyglyceryl-10 pentastearate • pyrus malus (apple) fruit extract • laminaria saccharina extract • cucumis sativus (cucumber) fruit extract • triticum vulgare (wheat) germ extract • acetyl hexapeptide-8 • scutellaria baicalensis root extract • hordeum vulgare (barley) extract\ extrait d'orge • polyquaternium-51 • oryzanol • glycyrrhetinic acid • octyldodecyl neopentanoate • trehalose • propylene glycol laurate • sucrose • glycerin • cholesterol • caffeine • sodium hyaluronate • linoleic acid • lecithin • squalane • propylene glycol stearate • urea • ammonium acryloyldimethyltaurate/vp copolymer • polyglyceryl-6 polyricinoleate • polysorbate 20 • tocopheryl acetate • sodium stearoyl lactylate • stearic acid • sorbitan laurate • xanthan gum • alumina • sodium pca • isopropyl titanium triisostearate • sodium dehydroacetate • triethoxycaprylylsilane • disodium edta • silica • chlorphenesin • phenoxyethanol • [+/- mica • ferric ferrocyanide (ci 77510) • ferric ammonium ferrocyanide (ci 77510) • chromium hydroxide green (ci 77289) • chromium oxide greens (ci 77288) • carmine (ci 75470) • titanium dioxide (ci 77891) • iron oxides (ci 77491) • iron oxides (ci 77492) • iron oxides (ci 77499) • yellow 5 lake (ci 19140) • blue 1 lake (ci 42090)] <iln40231>
- other information
- PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton
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INGREDIENTS AND APPEARANCE
BOBBI BROWN CC BROAD SPECTRUM SPF 25
octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-018 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.08175 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.0436 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.02725 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.01199 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.03597 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PENTYLENE GLYCOL (UNII: 50C1307PZG) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DOCOSANOL (UNII: 9G1OE216XY) TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R) OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C) PEG-40 STEARATE (UNII: ECU18C66Q7) APPLE (UNII: B423VGH5S9) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) CUCUMBER (UNII: YY7C30VXJT) WHEAT GERM (UNII: YR3G369F5A) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) ORYZANOL (UNII: SST9XCL51M) ENOXOLONE (UNII: P540XA09DR) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) TREHALOSE (UNII: B8WCK70T7I) PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3) SUCROSE (UNII: C151H8M554) GLYCERIN (UNII: PDC6A3C0OX) CHOLESTEROL (UNII: 97C5T2UQ7J) CAFFEINE (UNII: 3G6A5W338E) HYALURONATE SODIUM (UNII: YSE9PPT4TH) LINOLEIC ACID (UNII: 9KJL21T0QJ) SQUALANE (UNII: GW89575KF9) PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0) UREA (UNII: 8W8T17847W) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) POLYSORBATE 20 (UNII: 7T1F30V5YH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) STEARIC ACID (UNII: 4ELV7Z65AP) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) XANTHAN GUM (UNII: TTV12P4NEE) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE DISODIUM (UNII: 7FLD91C86K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CHLORPHENESIN (UNII: I670DAL4SZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) FERRIC FERROCYANIDE (UNII: TLE294X33A) FERRIC AMMONIUM FERROCYANIDE (UNII: 9R0NVI936I) CHROMIC OXIDE (UNII: X5Z09SU859) CARMINIC ACID (UNII: CID8Z8N95N) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64141-018-01 1 in 1 CARTON 10/01/2013 1 40 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 10/01/2013 Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 MANUFACTURE(64141-018) , REPACK(64141-018) , RELABEL(64141-018) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 REPACK(64141-018) , RELABEL(64141-018) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 202952982 MANUFACTURE(64141-018) , REPACK(64141-018) , RELABEL(64141-018) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 REPACK(64141-018) , RELABEL(64141-018) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 MANUFACTURE(64141-018) , REPACK(64141-018) , RELABEL(64141-018) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 REPACK(64141-018) , RELABEL(64141-018) Establishment Name Address ID/FEI Business Operations NORTHTEC PALC 102631997 REPACK(64141-018) , RELABEL(64141-018) Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 MANUFACTURE(64141-018) , REPACK(64141-018) , RELABEL(64141-018) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 REPACK(64141-018) , RELABEL(64141-018)
