Label: LBEL ESSENTIAL DEEP MOISTURIZING AND OXYGENATING SPF 20 NORMAL TO DRY SKIN- avobenzone, octinoxate, octisalate, and octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-507-01, 13537-507-02, 13537-507-03, 13537-507-04, view more13537-507-05, 13537-507-06, 13537-507-07, 13537-507-08 - 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 October 25, 2016
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
WATER, GLYCERIN, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, GLYCERYL STEARATE, DIMETHICONE, CYCLOHEXASILOXANE, TAPIOCA STARCH, ISOPROPYL PALMITATE, TOCOPHERYL ACETATE, IMPERATA CYLINDRICA ROOT EXTRACT, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, CETYL ALCOHOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, XANTHAN GUM, PEG-75 STEARATE, CETEARYL ISONONANOATE, FRAGRANCE, DIMETHICONOL, METHYLPROPANEDIOL, CETEARETH-20, CETEARYL ALCOHOL, BHT, PEG-8, TETRASODIUM EDTA, CETETH-20, SACCHAROMYCES LYSATE, STEARETH-20, SILANEDIOL SALICYLATE, SODIUM HYDROXIDE, TROMETHAMINE, METHYL PERFLUOROBUTYL ETHER, CARBOMER, ISODODECANE, CETEARETH-12, CETYL PALMITATE, DISODIUM SUCCINATE, GLUTAMIC ACID, GLYCINE, THREONINE, VALINE, POLYSILICONE-11, DECYL GLUCOSIDE, LINALOOL, d-LIMONENE, HEXYL CINNAMAL, BUTYLPHENYL METHYLPROPIONAL, ALPHA-ISOMETHYLIONONE.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 g Tube Box
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INGREDIENTS AND APPEARANCE
LBEL ESSENTIAL DEEP MOISTURIZING AND OXYGENATING SPF 20 NORMAL TO DRY SKIN
avobenzone, octinoxate, octisalate, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-507 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 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.03 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.05 g in 1 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.06 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) STARCH, TAPIOCA (UNII: 24SC3U704I) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CETYL ALCOHOL (UNII: 936JST6JCN) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) XANTHAN GUM (UNII: TTV12P4NEE) PEG-75 STEARATE (UNII: OT38R0N74H) CETEARYL ISONONANOATE (UNII: P5O01U99NI) METHYLPROPANEDIOL (UNII: N8F53B3R4R) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) EDETATE SODIUM (UNII: MP1J8420LU) CETETH-20 (UNII: I835H2IHHX) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) STEARETH-20 (UNII: L0Q8IK9E08) SILANEDIOL SALICYLATE (UNII: C054DF30K0) SODIUM HYDROXIDE (UNII: 55X04QC32I) TROMETHAMINE (UNII: 023C2WHX2V) METHYL PERFLUOROBUTYL ETHER (UNII: H637A50B7U) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) ISODODECANE (UNII: A8289P68Y2) CETEARETH-12 (UNII: 7V4MR24V5P) CETYL PALMITATE (UNII: 5ZA2S6B08X) SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3) GLUTAMIC ACID (UNII: 3KX376GY7L) GLYCINE (UNII: TE7660XO1C) THREONINE (UNII: 2ZD004190S) VALINE (UNII: HG18B9YRS7) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) 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:13537-507-02 1 in 1 BOX 10/25/2016 1 NDC:13537-507-01 50 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:13537-507-04 1 in 1 BOX 10/25/2016 2 NDC:13537-507-03 5 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:13537-507-06 1 in 1 CARTON 10/25/2016 3 NDC:13537-507-05 1 g in 1 PACKET; Type 0: Not a Combination Product 4 NDC:13537-507-08 1 in 1 CARTON 10/25/2016 4 NDC:13537-507-07 0.25 g 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 10/25/2016 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-507)