Label: BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15- avobenzone, octinoxate, and octisalate lipstick
- NDC Code(s): 64141-019-01
- 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 June 2, 2023
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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 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
petrolatum ■ microcrystalline wax\cera microcristallina\cire microcristalline ■ polybutene ■ bis-diglyceryl polyacyladipate-2 ■ octyldodecyl stearoyl stearate ■ beeswax\cera alba\cire d abeille ■ octyldodecanol ■ coffea arabica (coffee) seed extract ■ aloe barbadensis leaf extract ■ triticum vulgare (wheat) germ oil ■ persea gratissima (avocado) oil ■ olea europaea (olive) fruit oil ■ ozokerite ■ cholesterol ■ tocopheryl acetate ■ phytosphingosine ■ glycine soja (soybean) oil ■ glyceryl distearate ■ ricinus communis (castor) seed oil ■ caprylyl glycol ■ oleic acid ■ palmitic acid ■ fragrance (parfum) ■ alpha-isomethyl ionone ■ geraniol ■ citronellol ■ benzyl benzoate ■ titanium dioxide (ci 77891) ■ red 6 (ci 15850) <iln39883>
- Other information
- PRINCIPAL DISPLAY PANEL - 15 g Jar Carton
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INGREDIENTS AND APPEARANCE
BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15
avobenzone, octinoxate, and octisalate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-019 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3.5 g in 100 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C) YELLOW WAX (UNII: 2ZA36H0S2V) OCTYLDODECANOL (UNII: 461N1O614Y) ARABICA COFFEE BEAN (UNII: 3SW678MX72) ALOE VERA LEAF (UNII: ZY81Z83H0X) WHEAT GERM OIL (UNII: 14C97E680P) AVOCADO OIL (UNII: 6VNO72PFC1) OLIVE OIL (UNII: 6UYK2W1W1E) CHOLESTEROL (UNII: 97C5T2UQ7J) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) SOYBEAN OIL (UNII: 241ATL177A) GLYCERYL DISTEARATE (UNII: 73071MW2KM) CASTOR OIL (UNII: D5340Y2I9G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) OLEIC ACID (UNII: 2UMI9U37CP) PALMITIC ACID (UNII: 2V16EO95H1) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) GERANIOL (UNII: L837108USY) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) BENZYL BENZOATE (UNII: N863NB338G) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 6 (UNII: 481744AI4O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64141-019-01 1 in 1 CARTON 02/01/2002 1 15 g in 1 JAR; 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 02/01/2002 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(64141-019) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 pack(64141-019) , label(64141-019) , manufacture(64141-019)
