Label: MIAMI BEACH SPORT SUNSCREEN 50 BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray
- NDC Code(s): 13630-0125-4
- Packager: Prime Packaging Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 2, 2024
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- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
• spray liberally and spread evenly by hand 15 minutes before sun exposure
• reapply: • after 80 minutes of swimming or sweating
• inmediately after towel drying • at least every 2 hours
• hold container 4 to 6 inches from the skin to apply
• do not spray directly into face. Spray on hands then apply to face.
• do not apply in windy conditions • use in a well ventilated area
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun 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
- Other information
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- Miami Beach Sport Sunscreen Spray 50
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INGREDIENTS AND APPEARANCE
MIAMI BEACH SPORT SUNSCREEN 50 BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0125 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 27 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 24.75 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 36 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) Product Characteristics Color yellow (Light Yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0125-4 177 mL in 1 CAN; Type 0: Not a Combination Product 03/13/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/13/2018 Labeler - Prime Packaging Inc. (805987059) Registrant - Prime Packaging Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc 101946028 manufacture(13630-0125) , analysis(13630-0125) Establishment Name Address ID/FEI Business Operations Prime Packaging Inc. 805987059 label(13630-0125) , pack(13630-0125)
