FDA.reportPublic FDA data

Miami Beach Sea Sunscreen Lotion 30 Broad Spectrum SPF 30

Manufacturer
Prime Enterprises Inc.
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:08

Label at a glance#

ProductMiami Beach Sea Sunscreen Broad Spectrum SPF 30
Active ingredientOCTOCRYLENE, AVOBENZONE, OCTISALATE, HOMOSALATE
Label structure9 sections

Indications and 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.

Dosage and administration

• 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 ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

• protect this product from excessive heat and direct sun. • avoid contact with clothing to avoid staining.

Questions or comments?

OTC - QUESTIONS SECTION

Call 305.592.8565

Miami Beach Sea Sunscreen Lotion Broad Spectrum SPF 30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0260-42023-01-30C16284748780-1f386c649-edb7-0266-e053-dadaa90a7c1aMiami Beach Sea Sunscreen Lotion 30 Broad Spectrum SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0260-4Miami BeachSea Sunscreen Broad Spectrum SPF 30148 mL in 1 TUBELOTION1482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0260MIAMI BEACH SEA SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PRIME ENTERPRISES INC.]2Legacy NDC, 1 package rows20200118_6866cb26-9ec5-1b58-e053-2a91aa0a7b8d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-026058443-0260-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROLAMINE9O3K93S3TKIACT
ETHYLHEXYL PALMITATE2865993309IACT
OLETH-3BQZ26235UCIACT
DULSE7832HOY4ZQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
OCTOCRYLENE5A68WGF6WMACTIB
EDETATE DISODIUM7FLD91C86KIACT
CARBOMER 1342809Y72KV36IACT
BENZYL ALCOHOLLKG8494WBHIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
FUCUS SERRATUSV8K40WNW5BIACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
POLYAMIDE-8 (4500 MW)77723GV81AIACT
CHLORPHENESINI670DAL4SZIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
MACROCYSTIS PYRIFERAK31S3OG5C4IACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9c59f2e3-fc96-4ada-e053-2a95a90acbf46866cb26-9ec5-1b58-e053-2a91aa0a7b8d2020-01-17WarningsExact identifier
spl id: 9c59f2e3-fc96-4ada-e053-2a95a90acbf4
spl set id: 6866cb26-9ec5-1b58-e053-2a91aa0a7b8d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.