Label: TENSOLIFT- avobenzone, homosalate, octinoxate, octyocrelene, oxybenzone cream

  • 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 June 8, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients: Avobenzone (Butyl Methoxydibenzoylmethane) 3 percent. Homosalate 10 percent. Octinoxate (Ethylhexyl Methoxycinnamate) 4 percent. Octocrylene 2.5 percent. Oxybenzone (Benzophenone-3) 1 percent.
  • INACTIVE INGREDIENT

    Other Ingredients: Water (Aqua). C12-15 Alkyl Benzoate. Glycerin. Distarch Phsphate. Glyceryl Stearate. Cetyl Alcohol. Dimethicone. Benzotriazolyl Dodecyl P-Cresol. VP/Eicosene Copolymer. Butyrospermum Parkii (SHEA) Butter. Amaranthus Caudatus Seed Extract. Hydrolyzed Cucurbita Pepo (Pumkin) Seedcake. Hydrolyzed Elastin. Hydrolyzed Collagen. Ethylhexylglycerin. Allantoin. Sodium Hyaluronate. Pentylene Glycol. Urea. Lactic Acid. Sodium Lactate. Serine. Sorbitol. PEG-75 Stearate. Ceteth-20. Steareth-20. Polysorbate 20. Tribehenin. Acrylamide/Ammoniu, Acrylate Copolymer. Polyisobutene. Carbomer 2984. Trietholamine. Bisabolol. Tocopherol. Lecithin. Ascorbyl Palmitate. Butylene Glycol. Citric Acid. Glyceryl Oleate. Sodium Chloride. Disodium Edta. Potassium Sorbate. Phynoxyethanol. Methylparaben. Ethylparaben. butylparaben. Propylparaben. Isobutylparaben. Fragrance (Parfum). Limonene. Geraniol. Hydroxycitronellal. Linalool. Citronellel. Cinnamyl Alcohol. Citral. Benzyl Alcohol.
  • PURPOSE

    Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection.
    Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. Moderate sun protection product.
  • PRINCIPAL DISPLAY PANEL

    Natura Bisse
    Barcelona
    Tensolift Hand Cream
    Replenishing and lightening hand treatment with sunscreen
    Net Wt. 3 Oz. 90 ml.
    Made in Spain by
    Natura Bisse Int. S.A.
    Cerdanyola - 08290 Barcelona
    Herschel No 50 Colonia Anzures. Delegaciun Miguel Hidalgo.
    C.P. 11590 Mexico, D.F. RFC NBI0402132P0
    Not tested on animals
    image of label
  • INGREDIENTS AND APPEARANCE
    TENSOLIFT 
    avobenzone, homosalate, octinoxate, octyocrelene, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63730-216
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.76 g  in 90 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8.76 mL  in 90 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.65 mL  in 90 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.19 mL  in 90 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE921 mg  in 90 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BELLIS PERENNIS (UNII: 2HU33I03UY)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALLANTOIN (UNII: 344S277G0Z)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    UREA (UNII: 8W8T17847W)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SERINE (UNII: 452VLY9402)  
    SORBITOL (UNII: 506T60A25R)  
    CETETH-20 (UNII: I835H2IHHX)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERYL MONOOLEATE (UNII: 4PC054V79P)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    GERANIOL (UNII: L837108USY)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    LINALOOL, DL- (UNII: D81QY6I88E)  
    CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
    CITRAL (UNII: T7EU0O9VPP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63730-216-0190 mL in 1 TUBE
    2NDC:63730-216-022 mL in 1 TUBE
    3NDC:63730-216-0320 mL in 1 PACKAGE
    4NDC:63730-216-04200 mL in 1 PACKAGE
    5NDC:63730-216-0530 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/07/2010
    Labeler - Natura Bisse International, S.A. (464431576)
    Registrant - Natura Bisse International, S.A. (464431576)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natura Bisse International, S.A.464431576manufacture
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