SUNSORB REEF SAFE SPF50- homosalate, zinc oxide, octocrylene lotion

Sunsorb Reef Safe SPF50 by

Drug Labeling and Warnings

Sunsorb Reef Safe SPF50 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

Homosalate 10.0% w/w

Zinc Oxide   5.7% w/w

Octocrylene 5.0% 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

​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, Hydrogenated Polybutene, Polyglyceryl-4-Isostearate, Cyclomethicone, Octyl Stearate, Isopropyl Palmitate, Sunflower Oil, Emulsifying Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3 Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Caprylyl Glycol, 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

SUNSORB REEF SAFE SPF50 
homosalate, zinc oxide, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65008-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	57 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CYCLOMETHICONE (UNII: NMQ347994Z)
OCTYL STEARATE (UNII: 772Y4UFC8B)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65008-007-06	170 g in 1 TUBE; Type 0: Not a Combination Product	07/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/15/2019

Labeler - QS Key West Aloe, LLC (969600555)