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

Tensolift by

Drug Labeling and Warnings

Tensolift by is a Otc medication manufactured, distributed, or labeled by Natura Bisse International, S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

TENSOLIFT 
avobenzone, homosalate, octinoxate, octyocrelene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63730-216
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 mL  in 90 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.65 mL  in 90 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.19 mL  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 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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63730-216-01	90 mL in 1 TUBE
2	NDC: 63730-216-02	2 mL in 1 TUBE
3	NDC: 63730-216-03	20 mL in 1 PACKAGE
4	NDC: 63730-216-04	200 mL in 1 PACKAGE
5	NDC: 63730-216-05	30 mL in 1 TUBE

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

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