SUNSORB REEF SAFE SPF30- homosalate, octocrylene, avobenzone 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 ​Reef Safe ​SPF30

​Active Ingredients

Homosalate 7.0% w/w

Octocrylene 5.0% w/w

Avobenzone 2.0% 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, Cetyl Alcohol, Sorbitan Stearate, Allantoin, Sodium Ascorbic Phosphate, Tocopheryl Acetate, Retinyl Palmitate, Triethanolamine, C12-15 Alkyl Benzoate, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Carbomer, Phenoxyethanol, Disodium EDTA, Fragrance

​Other Information

- Protect this product from excessive heat and direct sun.

​Questions or Comments?

1-800-445-2563

6oz tube

2oz tube

SUNSORB REEF SAFE SPF30 
homosalate, octocrylene, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65008-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE70 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 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)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
ALLANTOIN (UNII: 344S277G0Z)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65008-006-06170 g in 1 TUBE; Type 0: Not a Combination Product10/18/2019
2NDC:65008-006-0259 g in 1 TUBE; Type 0: Not a Combination Product10/18/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/18/2019
Labeler - QS Key West Aloe, LLC (969600555)

Revised: 1/2022
 
QS Key West Aloe, LLC