SUNSORB SPF30- octinoxate, octisalate, oxybenzone, avobenzone, octocrylene lotion 
QS Key West Aloe, LLC

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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​Sunsorb ​SPF30

​Active Ingredients

Octinoxate 7.5% (w/w)

Octisalate  5.0% (w/w)

Oxybenzone 5.0% (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 and ask a doctor if

- Rash or irritation develops and lasts

​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

- ​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, 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

6oz tube

2oz Tube

SUNSORB SPF30 
octinoxate, octisalate, oxybenzone, avobenzone, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65008-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65008-003-06170 g in 1 TUBE; Type 0: Not a Combination Product02/26/2016
2NDC:65008-003-0257 g in 1 TUBE; Type 0: Not a Combination Product02/23/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/15/200410/18/2019
Labeler - QS Key West Aloe, LLC (969600555)

Revised: 10/2019
 
QS Key West Aloe, LLC