Label: SUNSORB REEF SAFE SPF50- homosalate, zinc oxide, octocrylene lotion
- NDC Code(s): 65008-007-06
- Packager: QS Key West Aloe, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 22, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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
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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
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNSORB REEF SAFE SPF50
homosalate, zinc oxide, octocrylene lotionProduct 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 Drug M020 07/15/2019 Labeler - QS Key West Aloe, LLC (969600555)
