Miami Beach Sea Sunscreen Spray 30

Manufacturer
Prime Packaging Inc. | Prime Enterprises Inc
Effective date
2024-05-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:03:51

Label at a glance#

ProductMiami Beach Sea Sunscreen 30 Broad Spectrum SPF 30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
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

• 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 ti...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Oxybenzone 4%

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

SPL UNCLASSIFIED SECTION

Flammable: Do not use near heat, flame, or while smoking.

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 eyes with water to remove. • Keep away from face to avoid breathing it. • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.

OTC - STOP USE 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

• 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

INACTIVE INGREDIENT SECTION

Acrylates/Octylacrylamide Copolymer, Fragrance, Propylene Glycol, Water, Pseudopterogorgia Elisabethae Plant Extract, SD Alcohol (Alcohol Denat.).

Other information

SPL UNCLASSIFIED SECTION

• protect this product from excessive heat and direct sun.

• may stain fabrics.

Question or comments?

OTC - QUESTIONS SECTION

Call 305.592.8565

Miami Beach Sport Sunscreen Spray 30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13630-0126-42024-05-02C16284748780-1f386c649-bb52-0266-e053-dadaa90a7c1aMiami Beach Sea Sunscreen Spray 30
13630-0126-42023-01-30C16284748780-1f386c649-bb52-0266-e053-dadaa90a7c1aMiami Beach Sea Sunscreen Spray 30

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13630-012613630-0126-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

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
177d3296-bec1-c030-e063-6394a90a577d67773563-6776-4fe2-e053-2a91aa0acb012024-05-02WarningsExact identifier
spl id: 177d3296-bec1-c030-e063-6394a90a577d
spl set id: 67773563-6776-4fe2-e053-2a91aa0acb01

Reported adverse events (FAERS/openFDA)#

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