Label: MIAMI BEACH SEA SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0260-4 - Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 17, 2020
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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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 hours • 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 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
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Inactive ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Caprylic/Capric Triglyceride, Chlorphenesin, Diethylhexyl Syringylidene-malonate, Disodium EDTA, Ethylhexyl Palmitate, Fragrance, Fucus Serratus (Seaweed) Extract, Macrocystis Pyrifera (Kelp) Extract, Oleth-3, Palmaria Palmata (Algae) Extract, Polyamide-8, Propylene Glycol, Sodium Ascorbyl Phosphate, Sorbitol, Tocopherol, Triethanolamine, Water
- Other information
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- Miami Beach Sea Sunscreen Lotion Broad Spectrum SPF 30
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INGREDIENTS AND APPEARANCE
MIAMI BEACH SEA SUNSCREEN BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0260 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 99.6 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29.88 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 49.8 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 99.6 mg in 1 mL Inactive Ingredients Ingredient Name Strength TROLAMINE (UNII: 9O3K93S3TK) ETHYLHEXYL PALMITATE (UNII: 2865993309) OLETH-3 (UNII: BQZ26235UC) DULSE (UNII: 7832HOY4ZQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) EDETATE DISODIUM (UNII: 7FLD91C86K) CARBOMER 1342 (UNII: 809Y72KV36) BENZYL ALCOHOL (UNII: LKG8494WBH) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) FUCUS SERRATUS (UNII: V8K40WNW5B) POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A) CHLORPHENESIN (UNII: I670DAL4SZ) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0260-4 148 mL in 1 TUBE; Type 0: Not a Combination Product 03/27/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/27/2018 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0260) , manufacture(58443-0260) , label(58443-0260) , analysis(58443-0260)
