Label: LBEL ESSENTIAL DEEP MOISTURIZING AND OXYGENATING SPF 20 NORMAL TO OILY SKIN- avobenzone, octinoxate, octisalate, and octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-957-01, 13537-957-02, 13537-957-03, 13537-957-04, view more13537-957-05, 13537-957-06, 13537-957-07, 13537-957-08 - Packager: Ventura Corporation LTD
- 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 11, 2016
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
WATER, GLYCERIN, BUTYLENE GLYCOL, ALUMINUM STARCH OCTENYLSUCCINATE, C12-15 ALKYL BENZOATE, CYCLOHEXASILOXANE, CETEARYL ALCOHOL, DIMETHICONE, TOCOPHERYL ACETATE, GLYCERYL STEARATE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, CETYL ALCOHOL, CETEARETH-20, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, FRAGRANCE, XANTHAN GUM, PEG-75 STEARATE, ENANTIA CHLORANTHA BARK EXTRACT, METHYLPROPANEDIOL, BHT, TETRASODIUM EDTA, SACCHAROMYCES LYSATE, CETETH-20, STEARETH-20, SILANEDIOL SALICYLATE, SODIUM HYDROXIDE, TROMETHAMINE, METHYL PERFLUOROBUTYL ETHER, ISODODECANE, DISODIUM SUCCINATE, SILICA, GLUTAMIC ACID, GLYCINE, THREONINE, VALINE, POLYSILICONE-11, OLEANOLIC ACID, BLUE 1, DECYL GLUCOSIDE, LINALOOL, d-LIMONENE, HEXYL CINNAMAL, BUTYLPHENYL METHYLPROPIONAL, ALPHA-ISOMETHYL IONONE
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 5 ml Tube Box
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INGREDIENTS AND APPEARANCE
LBEL ESSENTIAL DEEP MOISTURIZING AND OXYGENATING SPF 20 NORMAL TO OILY SKIN
avobenzone, octinoxate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-957 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.03 g in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.03 g in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.05 g in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.06 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) CETYL ALCOHOL (UNII: 936JST6JCN) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) XANTHAN GUM (UNII: TTV12P4NEE) PEG-75 STEARATE (UNII: OT38R0N74H) ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A) METHYLPROPANEDIOL (UNII: N8F53B3R4R) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) EDETATE SODIUM (UNII: MP1J8420LU) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) CETETH-20 (UNII: I835H2IHHX) STEARETH-20 (UNII: L0Q8IK9E08) SILANEDIOL SALICYLATE (UNII: C054DF30K0) SODIUM HYDROXIDE (UNII: 55X04QC32I) TROMETHAMINE (UNII: 023C2WHX2V) METHYL PERFLUOROBUTYL ETHER (UNII: H637A50B7U) ISODODECANE (UNII: A8289P68Y2) SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLUTAMIC ACID (UNII: 3KX376GY7L) GLYCINE (UNII: TE7660XO1C) THREONINE (UNII: 2ZD004190S) VALINE (UNII: HG18B9YRS7) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) OLEANOLIC ACID (UNII: 6SMK8R7TGJ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) LINALOOL, (+/-)- (UNII: D81QY6I88E) LIMONENE, (+)- (UNII: GFD7C86Q1W) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-957-02 1 in 1 BOX 07/08/2016 1 NDC:13537-957-01 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:13537-957-04 1 in 1 BOX 07/08/2016 2 NDC:13537-957-03 5 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:13537-957-06 1 in 1 CARTON 07/08/2016 3 NDC:13537-957-05 1 mL in 1 PACKET; Type 0: Not a Combination Product 4 NDC:13537-957-08 1 in 1 CARTON 07/08/2016 4 NDC:13537-957-07 0.25 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 07/08/2016 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-957)