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.
Miami Beach Kids Sunscreen Lotion Broad Spectrum SPF 50
- 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 23:03:07
Label at a glance#
ProductMiami Beach Kids Sunscreen Broad Spectrum SPF 50
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE
Label structure8 sections
Dosage and administration
• apply liberally 15 minutes before sun exposure • reapply: • after 40 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
Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 2.75%
Purpose
Sunscreen
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.
Warnings
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
• apply liberally 15 minutes before sun exposure
• reapply: • after 40 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
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Beta-Carotene, C12-15 Alkyl Benzoate, Carbomer, 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
Other information
• protect this product from excessive heat and direct sun. • may stain fabrics.
Miami Beach Kids Sunscreen Lotion Broad Spectrum SPF 50
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58443-0256-4 | 2023-01-30 | C162847 | 48780-1 | f386c649-d7ff-0266-e053-dadaa90a7c1a | Miami Beach Kids Sunscreen Lotion Broad Spectrum SPF 50 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58443-0256-4 | Miami BeachKids Sunscreen Broad Spectrum SPF 50 | 177 mL in 1 BOTTLE | LOTION | 177 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58443-0256 | MIAMI BEACH KIDS SUNSCREEN BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PRIME ENTERPRISES INC.] | 2 | Legacy NDC, 1 package rows | 20200118_678b9575-3271-9c42-e053-2a91aa0a5c91.zip |
Products#
Every source-derived product name is available through these pages.
- Miami Beach Kids Sunscreen Broad Spectrum SPF 50
- Avobenzone, Homosalate, Octisalate, Octocrylene
- COCOA BUTTER
- .ALPHA.-TOCOPHEROL ACETATE
- BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER
- SORBITAN MONOOLEATE
- CARBOMER 1342
- ALOE VERA LEAF
- ALKYL (C12-15) BENZOATE
- CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
- DIMETHICONE
- EDETATE DISODIUM
- EDETIC ACID
- SUNFLOWER OIL
- CORN OIL
- .BETA.-CAROTENE
- HYPROMELLOSE, UNSPECIFIED
- PHENOXYETHANOL
- ETHYLHEXYLGLYCERIN
- HIGH DENSITY POLYETHYLENE
- POLYSORBATE 20
- PROPYLENE GLYCOL
- WATER
- PSEUDOPTEROGORGIA ELISABETHAE
- APRICOT KERNEL OIL
- SOLANUM LYCOPERSICUM FRUITING TOP
- ROSEMARY
- SODIUM HYDROXIDE
- AVOBENZONE
- OCTISALATE
- OCTOCRYLENE
- HOMOSALATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58443-0256 | 58443-0256-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 9c59ea17-cd7e-7ccb-e053-2995a90ada4c | 678b9575-3271-9c42-e053-2a91aa0a5c91 | 2020-01-17 | Warnings | 9c59ea17-cd7e-7ccb-e053-2995a90ada4c 678b9575-3271-9c42-e053-2a91aa0a5c91 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.