Active Ingredients
Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 2.75%
Miami Beach
FDA Label NDC 13630-0104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Packaging Inc. for the product Miami Beach (NDC 13630-0104). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Do not use on damaged or broken skin
Otc - When Using
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
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- 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
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
- protect this product from excessive heat and direct sun
- may stain fabrics
Question Or Comments?
Call 305.471.7989
Miami Beach Spf 50 C/S Sunscreen
Principal Display Image (13630 0104 4)
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