KEY WEST TAN SPF15- octinoxate, octisalate, oxybenzone, avobenzone, octocrylene lotion

Key West Tan SPF15 by

Drug Labeling and Warnings

Key West Tan SPF15 by is a Otc medication manufactured, distributed, or labeled by QS Key West Aloe, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​ ​Active Ingredients

Octinoxate 5.0% (w/w)

Octisalate  3.0% (w/w)

Oxybenzone 2.0% (w/w)

Avobenzone 2.0% (w/w)

Octocrylene 1.5% (w/w)

​Purpose

Sunscreen

​Uses

- Helps prevent sunburn

- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

​Warnings

​For external use only

Do not use on damaged or broken skin

​When using this product​

- Keep out of eyes.  Rinse with water to remove.

STOP USE

​Stop use and ask a doctor if​

- Rash or irritation develops and lasts

KEEP OUT OF REACH OF CHILDREN

​Keep out of reach of children.​

- If product is swallowed, get medical help or contact a Poison Control Center right away.

​Directions

- Apply liberally 15 minutes before sun exposure

- Reapply

  - After 80 minutes of swimming or sweating

  - Immediately after towel drying

  - At least every 2 hrs

- ​Sun Protection Measures​.  Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease the risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other skin protection measures including:

  - limit time in the sun, especially from 10 a.m. - 2 p.m.

  - wear long-sleeve shirts, pants, hats, and sunglasses

ASK DOCTOR/PHARMACIST

- ​Children under 6 months:​ Ask a doctor

​Inactive Ingredients:

Water, Aloe Barbadensis Leaf Extract, Adipic Acid/Diethylene Glycol Glycerin Crosspolymer, Polycrylene, Isopropyl Myristate, Propylene Glycol, Hydrogenated Polyisobutene, Polyethylene, Allantoin, Sodium Ascorbic Phosphate, Tocopheryl Acetate, Retinyl Palmitate, Cetyl Alcohol, Triethanolamine, C12-15 Alkyl Benzoate, Sorbitan Stearate, Fragrance, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Carbomer, Caprylyl Glycol, Disodium EDTA, Methylisothiazolinone

​Other Information

- Protect this product from excessive heat and direct sun.

​Questions or Comments?

1-800-445-2563

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KEY WEST TAN SPF15 
octinoxate, octisalate, oxybenzone, avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65008-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	15 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CETYL ALCOHOL (UNII: 936JST6JCN)
TROLAMINE (UNII: 9O3K93S3TK)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65008-004-08	227 g in 1 TUBE; Type 0: Not a Combination Product	02/26/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/07/2004

Labeler - QS Key West Aloe, LLC (969600555)