Tensolift

Drug Labeling and Warnings

Drug Details [pdf]

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

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

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
  

TENSOLIFT 
avobenzone, homosalate, octinoxate, octyocrelene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63730-393
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.76 g  in 90 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8.76 mg  in 90 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.65 mg  in 90 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.19 mg  in 90 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	921 mg  in 90 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
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 MONOLINOLEATE (UNII: 4763AXI84L)
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, (+)- (UNII: F4VNO44C09)
CINNAMYL ALCOHOL (UNII: SS8YOP444F)
CITRAL (UNII: T7EU0O9VPP)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63730-393-01	90 mL in 1 TUBE; Type 0: Not a Combination Product	03/08/2017
2	NDC: 63730-393-02	2 mL in 1 TUBE; Type 0: Not a Combination Product	03/08/2017
3	NDC: 63730-393-03	20 mL in 1 PACKAGE; Type 0: Not a Combination Product	03/08/2017
4	NDC: 63730-393-04	200 mL in 1 PACKAGE; Type 0: Not a Combination Product	03/08/2017
5	NDC: 63730-393-05	30 mL in 1 TUBE; Type 0: Not a Combination Product	03/08/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/07/2010	06/15/2019

Labeler - Natura Bisse International, S.A. (464431576)

Registrant - Natura Bisse International, S.A. (464431576)

Establishment
Name	Address	ID/FEI	Business Operations
Natura Bisse International, S.A.		464431576	manufacture(63730-393)

Revised: 6/2019

Document Id: 8b5ba9b3-bf9e-11fc-e053-2a95a90a0247

34390-5

Set id: 4a366379-9a4e-729a-e054-00144ff88e88

Version: 5

Effective Time: 20190615