![3LAB WW DAY SPF40 BROAD SPECTRUM (HOMOSALATE, OCTISALATE,AVOBENZONE,OCTOCRYLENE) CREAM [3LAB]](https://medic.hrt.org//dailymed/images/60a5dc14-3f82-8414-e053-2991aa0ad34a/3LAB_WW DAY SPF40_Bottle.jpg)
![3LAB WW DAY SPF40 BROAD SPECTRUM (HOMOSALATE, OCTISALATE,AVOBENZONE,OCTOCRYLENE) CREAM [3LAB]](https://medic.hrt.org//dailymed/images/60a5dc14-3f82-8414-e053-2991aa0ad34a/3LAB_WW DAY SPF40_UnitBox.jpg)
- Bottle Packaging Label
- Outer Packaging Label
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INGREDIENTS AND APPEARANCE
3LAB WW DAY SPF40 BROAD SPECTRUM
homosalate, octisalate,avobenzone,octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76159-204 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 26 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 0.544504 mg in 1 mL LAVANDIN OIL (UNII: 9RES347CKG) 0.2 mg in 1 mL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) 14.475 mg in 1 mL ETHYLHEXYL PALMITATE (UNII: 2865993309) 85 mg in 1 mL DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) 6.16 mg in 1 mL DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF) 85.957 mg in 1 mL ISODODECANE (UNII: A8289P68Y2) 455.487801 mg in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.0004 mg in 1 mL EDETATE DISODIUM (UNII: 7FLD91C86K) 0.00004 mg in 1 mL TOCOPHEROL (UNII: R0ZB2556P8) 0.083 mg in 1 mL SODIUM PHOSPHATE (UNII: SE337SVY37) 0.0003 mg in 1 mL SQUALANE (UNII: GW89575KF9) 0.0003 mg in 1 mL ORANGE OIL (UNII: AKN3KSD11B) 1.6 mg in 1 mL CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) 32 mg in 1 mL ERYTHROPOIETIN (UNII: 64FS3BFH5W) 0.00001 mg in 1 mL SESAME OIL (UNII: QX10HYY4QV) 0.8 mg in 1 mL MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 17.995 mg in 1 mL XANTHAN GUM (UNII: TTV12P4NEE) 0.001 mg in 1 mL MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0) 0.15 mg in 1 mL ISOMALT (UNII: S870P55O2W) 0.093 mg in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.525 mg in 1 mL POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) 32 mg in 1 mL AZADIRACHTA INDICA BARK (UNII: G580B439YI) 2.85 mg in 1 mL CERAMIDE 3 (UNII: 4370DF050B) 0.00005 mg in 1 mL PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO) 8 mg in 1 mL SHEA BUTTER (UNII: K49155WL9Y) 0.00005 mg in 1 mL WINE GRAPE (UNII: 3GOV20705G) 0.0008 mg in 1 mL BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 50 mg in 1 mL .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 1 mg in 1 mL GOLD (UNII: 79Y1949PYO) 0.000001 mg in 1 mL OLIVE OIL (UNII: 6UYK2W1W1E) 0.0003 mg in 1 mL BERGAMOT OIL (UNII: 39W1PKE3JI) 1 mg in 1 mL MALUS DOMESTICA WHOLE (UNII: 04W636S1V3) 0.009 mg in 1 mL DIACETYL BOLDINE (UNII: 37727Z7M0I) 0.005 mg in 1 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.0022 mg in 1 mL LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 0.00224 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76159-204-01 1 in 1 CARTON 05/27/2016 1 50 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 not final part352 05/27/2016 Labeler - 3LAB (162333277) Registrant - COSMAX USA, Inc.(Cosmax USA, Corporation) (010990210) Establishment Name Address ID/FEI Business Operations COSMAX USA, Inc.(Cosmax USA, Corporation) 010990210 manufacture(76159-204) , analysis(76159-204) , pack(76159-204) , label(76159-204)
