Label: BOBBI BROWN SKIN FOUNDATION BROAD SPECTRUM SPF 15- octinoxate and titanium dioxide liquid
- NDC Code(s): 64141-013-01
- 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 27, 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
water\aqua\eau • methyl trimethicone • neopentyl glycol diethylhexanoate • isononyl isononanoate • glycerin • pentylene glycol • lauryl peg-9 polydimethylsiloxyethyl dimethicone • hdi/trimethylol hexyllactone crosspolymer • talc • boron nitride • disteardimonium hectorite • stearic acid • palmitic acid • dimethicone • lecithin • aluminum dimyristate • tocopherol • myristic acid • silica • magnesium ascorbyl phosphate • sodium chloride • sodium citrate • sorbic acid • chlorphenesin • phenoxyethanol • [+/- titanium dioxide (ci 77891) • iron oxides (ci 77491, ci 77492, ci 77499)] <iln34969>
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
BOBBI BROWN SKIN FOUNDATION BROAD SPECTRUM SPF 15
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-013 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 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) PENTYLENE GLYCOL (UNII: 50C1307PZG) TALC (UNII: 7SEV7J4R1U) BORON NITRIDE (UNII: 2U4T60A6YD) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITIC ACID (UNII: 2V16EO95H1) DIMETHICONE (UNII: 92RU3N3Y1O) ALUMINUM DIMYRISTATE (UNII: J2KA067N9O) TOCOPHEROL (UNII: R0ZB2556P8) MYRISTIC ACID (UNII: 0I3V7S25AW) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBIC ACID (UNII: X045WJ989B) CHLORPHENESIN (UNII: I670DAL4SZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:64141-013-01 1 in 1 CARTON 09/01/2012 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 09/01/2012 Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations JO COSMETICS 691485222 manufacture(64141-013)
