Label: BOBBI BROWN TINTED MOISTURIZER BROAD SPECTRUM SPF 15- octinoxate and titanium dioxide lotion
- NDC Code(s): 64141-027-01
- 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 April 27, 2023
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- 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 • phenyl trimethicone • butylene glycol • pentaerythrityl tetraoctanoate • simmondsia chinensis (jojoba) seed oil • petrolatum • biosaccharide gum - 1 • steareth-21 • glyceryl stearate • sodium hyaluronate • tocopheryl acetate • polymethyl methacrylate • magnesium aluminum silicate • ethylhexylglycerin • caprylyl glycol • cetyl alcohol • acrylamide/sodium acryloyldimethyltaurate copolymer • peg-12 dimethicone • isohexadecane • lecithin • xanthan gum • steareth-2 • potassium stearate • citric acid • fragrance (parfum) • limonene • linalool • benzyl salicylate • polysorbate 80 • disodium edta • phenoxyethanol • sorbic acid • [+/- titanium dioxide (ci 77891) • iron oxides (ci 77491, ci 77492, ci 77499)] <iln33789>
- Other information
- PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton
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INGREDIENTS AND APPEARANCE
BOBBI BROWN TINTED MOISTURIZER BROAD SPECTRUM SPF 15
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-027 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897) JOJOBA OIL (UNII: 724GKU717M) PETROLATUM (UNII: 4T6H12BN9U) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) STEARETH-21 (UNII: 53J3F32P58) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYALURONATE SODIUM (UNII: YSE9PPT4TH) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETYL ALCOHOL (UNII: 936JST6JCN) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) ISOHEXADECANE (UNII: 918X1OUF1E) XANTHAN GUM (UNII: TTV12P4NEE) STEARETH-2 (UNII: V56DFE46J5) POTASSIUM STEARATE (UNII: 17V812XK50) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LINALOOL, (+/-)- (UNII: D81QY6I88E) BENZYL SALICYLATE (UNII: WAO5MNK9TU) POLYSORBATE 80 (UNII: 6OZP39ZG8H) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PHENOXYETHANOL (UNII: HIE492ZZ3T) SORBIC ACID (UNII: X045WJ989B) 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:64141-027-01 1 in 1 CARTON 01/01/2001 05/01/2025 1 50 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 final M020 01/01/2001 Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations PALC 078364654 pack(64141-027) , label(64141-027) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 pack(64141-027) , label(64141-027) , manufacture(64141-027) Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture(64141-027) , pack(64141-027) , label(64141-027) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 manufacture(64141-027) , pack(64141-027) , label(64141-027) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 manufacture(64141-027) , pack(64141-027) , label(64141-027) Establishment Name Address ID/FEI Business Operations Northtec LLC 943871157 pack(64141-027) , label(64141-027) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 pack(64141-027) , label(64141-027)