Key west tan spf15 lotion

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 useon damaged or broken skin

When using this product

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

Otc - stop use section

Stop use and ask a doctor if

- Rash or irritation develops and lasts

Otc - keep out of reach of children section

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

Otc - ask doctor/pharmacist section

- 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

Ingredients and appearance - Product information

Key west tan spf15 lotion- Octinoxate, octisalate, oxybenzone, avobenzone, octocrylene

Product information

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

Active Ingredient/Active Moiety

Ingredient Name Strength
Octinoxate ( UNII: 4Y5P7MUD51)( Octinoxate - UNII: 4Y5P7MUD51 ) 50 mgin 1 g
Octisalate ( UNII: 4X49Y0596W)( Octisalate - UNII: 4X49Y0596W ) 30 mgin 1 g
Oxybenzone ( UNII: 95OOS7VE0Y)( Oxybenzone - UNII: 95OOS7VE0Y ) 20 mgin 1 g
Avobenzone ( UNII: G63QQF2NOX)( Avobenzone - UNII: G63QQF2NOX ) 20 mgin 1 g
Octocrylene ( UNII: 5A68WGF6WM)( Octocrylene - UNII: 5A68WGF6WM ) 15 mgin 1 g

Inactive Ingredients

Ingredient Name Code
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)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 65008-004-08 227g in 1 TUBE 2015/02/26

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part352 USA 2015/02/26

Labeler - QS Key West Aloe, LLC( 969600555)

Package label.principal display panel