FDA.reportPublic FDA data

Miami Beach

Manufacturer
Prime Packaging Inc. | Prime Enterprises Inc
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:02

Label at a glance#

ProductMiami Beach SPF 50 Kids C/S Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
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 and sweating immediately 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 increa...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

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.

  • keep away from face to avoid breathing it
  • Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F

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 and sweating
  • immediately 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 INGREDIENT SECTION

Water (Aqua), Styrene/Acrylates Copolymer, Homosalate, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane, Sorbitol, Octocrylene, Dimethicone, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Phenoxyethanol, Potassium Cetyl Phosphate, Fragrance (Parfum), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Disodium EDTA, Tocopheryl Acetate, Butylphenyl Methylpropional, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Hexyl Cinnamal, Linalool, Geraniol, Alpha-Isomethyl Ionone, Caprylic/Capric Triglyceride, Benzyl Salicylate, Propylene Glycol, Hydroxycitronellal, Limonene, Crambe Maritima Extract, Pseudopterogorgia Elisabethae Plant Extract

Other Information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun
  • may stain fabrics

Question or comments?

OTC - QUESTIONS SECTION

Call 305.471.7989

Miami Beach SPF 50 C/S Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display ImagePrincipal Display Image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13630-0104-42023-01-30C16284748780-1f386c649-adc0-0266-e053-dadaa90a7c1aMiami Beach SPF 50 Kids C/S Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13630-0104-4Miami BeachSPF 50 Kids C/S Sunscreen177 mL in 1 CANSPRAY1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13630-0104MIAMI BEACH SPF 50 KIDS C/S SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]2Legacy NDC, 1 package rows20200118_2bd8159f-c381-36b3-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13630-010413630-0104-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER7K68DGG29PIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
DIMETHICONE92RU3N3Y1OIACT
CRAMBE MARITIMA LEAFNO0DI2V62BIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
ALOE VERA LEAFZY81Z83H0XIACT
SORBITOL506T60A25RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE DISODIUM7FLD91C86KIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
PSEUDOPTEROGORGIA ELISABETHAEUDY3H1OUX5IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
9c5c735f-5822-37d1-e053-2995a90ae48c2bd8159f-c381-36b3-e054-00144ff88e882020-01-17WarningsExact identifier
spl id: 9c5c735f-5822-37d1-e053-2995a90ae48c
spl set id: 2bd8159f-c381-36b3-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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