Miami Beach Faces Sunscreen Lotion 50

Manufacturer
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 Faces Sunscreen 50 Broad Spectrum SPF 50
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE
Label structure8 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 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.

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.

Other Information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics or surfaces

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

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Beta-Carotene, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Carbomer, Crambe Maritima Leaf Extract, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Prunus Armeniaca (Apricot) Kernel Oil, Pseudopterogorgia Elisabethae Plant Extract, Rosmarinus Officinalis (Rosemarry) Leaf Extract, Sodium Hydroxide, Solanum Lycopersicum (Tomato) Fruit/Leaf/Stem Extract, Sorbitan Oleate, Styrene/Acrylates Copolymer, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water, Zea Mays (Corn) Oil

Miami Beach Faces Sunscreen Lotion 50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0255-32024-05-02C16284748780-1f386c649-b4a2-0266-e053-dadaa90a7c1aMiami Beach Faces Sunscreen Lotion 50
58443-0255-32023-01-30C16284748780-1f386c649-b4a2-0266-e053-dadaa90a7c1aMiami Beach Faces Sunscreen Lotion 50

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-025558443-0255-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 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
177e2bd3-85fe-9442-e063-6294a90a6950677acb24-0e17-6c1e-e053-2a91aa0a7a2b2024-05-02WarningsExact identifier
spl id: 177e2bd3-85fe-9442-e063-6294a90a6950
spl set id: 677acb24-0e17-6c1e-e053-2a91aa0a7a2b

Reported adverse events (FAERS/openFDA)#

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