TENSOLIFT - avobenzone, homosalate, octinoxate, octyocrelene, oxybenzone cream 
Natura Bisse International, S.A.

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.

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Tensolift

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

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.

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.

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
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

Revised: 6/2010
Document Id: c2504171-ecca-4d8b-aa6a-f9df73bbfb78
Set id: 93bfdc68-c502-4690-94f7-59004c659b16
Version: 2
Effective Time: 20100608
 
Natura Bisse International, S.A.