Label: DAYWEAR BB ANTI OXIDANT BEAUTY BENEFIT BROAD SPECTRUM SPF 35- octinoxate, octisalate, oxybenzone, and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 11559-015-01 - Packager: ESTEE LAUDER 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 April 6, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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 • pentylene glycol • phenyl trimethicone • glyceryl stearate • behenyl alcohol • trioctyldodecyl citrate • polymethylsilsesquioxane • octyldodecyl stearoyl stearate • peg-40 stearate • polyglyceryl-10 pentastearate • gentiana lutea (gentian) root extract • polygonum cuspidatum root extract • thermus thermophillus ferment • hordeum vulgare (barley) extract\extrait d' orge • fumaria officinalis flower/leaf/stem extract • citrus medica limonum (lemon) fruit extract • hydrolyzed rice bran extract • laminaria saccharina extract • hydrolyzed rice extract • rosmarinus officinalis (rosemary) leaf extract • artemia extract • vitis vinifera (grape) seed extract • triticum vulgare (wheat) germ extract • cholesterol • caffeine • propylene glycol stearate • octyldodecyl neopentanoate • polyglyceryl-6 polyricinoleate • tocopheryl acetate • sucrose • glycerin • sodium stearoyl lactylate • linoleic acid • lecithin • squalane • sodium pca • urea • isopropyl titanium triisostearate • ergothioneine • sodium dehydroacetate • tetrahexyldecyl ascorbate • polysorbate 20 • sorbitan laurate • sodium hyaluronate • citric acid • propylene glycol laurate • glycyrrhetinic acid • trehalose • polyquaternium-51 • hydrogenated lecithin • fumaric acid • alumina • palmitoyl hydroxypropyltrimonium amylopectin/glycerin crosspolymer • ammonium acryloyldimethyltaurate/vp copolymer • cyclodextrin • nordihydroguaiaretic acid • ascorbyl tocopheryl maleate • xanthan gum • stearic acid • silica • fragrance (parfum) • ethylbisiminomethylguaiacol manganese chloride • pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate • disodium edta • phenoxyethanol • chlorphenesin • [+/- titanium dioxide (ci 77891) • zinc oxide (ci 77947) • iron oxides (ci 77491, ci 77492, ci 77499) • yellow 5 lake (ci 19140) • chromium oxide greens (ci 77288) • mica • ferric ferrocyanide (ci 77510) • chromium hydroxide green (ci 77289) • carmine (ci 75470) • bismuth oxychloride (ci 77163) • blue 1 lake (ci 42090)] [iln38365]
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ml Carton
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INGREDIENTS AND APPEARANCE
DAYWEAR BB ANTI OXIDANT BEAUTY BENEFIT BROAD SPECTRUM SPF 35
octinoxate, octisalate, oxybenzone, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 mL in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2.5 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.1 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PENTYLENE GLYCOL (UNII: 50C1307PZG) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DOCOSANOL (UNII: 9G1OE216XY) OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C) PEG-40 STEARATE (UNII: ECU18C66Q7) GENTIANA LUTEA ROOT (UNII: S72O3284MS) POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7) HORDEUM VULGARE ROOT (UNII: 790S39483Z) FUMARIA OFFICINALIS FLOWERING TOP (UNII: VH659J61ZL) LEMON (UNII: 24RS0A988O) SACCHARINA LATISSIMA THALLUS (UNII: 68CMP2MB55) ROSEMARY (UNII: IJ67X351P9) VITIS VINIFERA SEED (UNII: C34U15ICXA) WHEAT GERM (UNII: YR3G369F5A) CHOLESTEROL (UNII: 97C5T2UQ7J) CAFFEINE (UNII: 3G6A5W338E) PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SUCROSE (UNII: C151H8M554) GLYCERIN (UNII: PDC6A3C0OX) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) LINOLEIC ACID (UNII: 9KJL21T0QJ) SQUALANE (UNII: GW89575KF9) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) UREA (UNII: 8W8T17847W) ERGOTHIONEINE (UNII: BDZ3DQM98W) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) POLYSORBATE 20 (UNII: 7T1F30V5YH) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPYLENE GLYCOL LAURATES (UNII: 40KT317HGP) ENOXOLONE (UNII: P540XA09DR) TREHALOSE (UNII: B8WCK70T7I) FUMARIC ACID (UNII: 88XHZ13131) ALUMINUM OXIDE (UNII: LMI26O6933) MASOPROCOL (UNII: 7BO8G1BYQU) XANTHAN GUM (UNII: TTV12P4NEE) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) ZINC OXIDE (UNII: SOI2LOH54Z) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) CHROMIC OXIDE (UNII: X5Z09SU859) MICA (UNII: V8A1AW0880) FERRIC FERROCYANIDE (UNII: TLE294X33A) COCHINEAL (UNII: TZ8Z31B35M) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-015-01 1 in 1 CARTON 1 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 09/01/2011 Labeler - ESTEE LAUDER INC (005914387) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(11559-015) , REPACK(11559-015) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(11559-015) , RELABEL(11559-015) , REPACK(11559-015) Establishment Name Address ID/FEI Business Operations Estee Lauder Inc. 042918826 MANUFACTURE(11559-015) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(11559-015) , RELABEL(11559-015) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(11559-015) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(11559-015) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(11559-015) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(11559-015) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(11559-015) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(11559-015) , RELABEL(11559-015) , REPACK(11559-015) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(11559-015) , RELABEL(11559-015) , REPACK(11559-015) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(11559-015) , RELABEL(11559-015) , REPACK(11559-015) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(11559-015) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(11559-015) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(11559-015) , RELABEL(11559-015)
