NDC | 65008-004-08 |
Set ID | ffc74655-dae4-43e8-adee-f88a71eebb9d |
Category | HUMAN OTC DRUG LABEL |
Packager | QS Key West Aloe, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients
- Purpose
- Uses
- Warnings
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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
-
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
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
KEY WEST TAN SPF15
octinoxate, octisalate, oxybenzone, avobenzone, octocrylene lotionProduct 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)