Sea Star Sparkle SPF-50 PARTY CAKE

OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE TOPICAL HUMAN OTC DRUG

Sea Star Sparkle SPF-50 PARTY CAKE is an FDA drug label for the active ingredient OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE manufactured by MJ Products Association, LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231111.

Generic name
OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE
Manufacturer
MJ Products Association, LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
72085-148
Application
M020
Label effective
20231111

Active ingredients

Active Ingredients Octinoxate 7.50% Octisalate 5.00% Octocrylene 5.00% Zinc Oxide 5.00% Purpose Sunscreen

Indications & Usage

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 & Administration

Directions Apply liberally 15 minutes before sun exposure. REAPPLY: At least every two-hours. Immediately after swimming, sweating or towel drying. : Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: SUN PROTECTION MEASURES Limit time in the sun, especially between 10am to 2pm. Wear long sleeve shirts, pants, hats and sunglasses. For children under 6 months, consult a physician.

Contraindications

Not available.

Warnings

Warnings For external use only Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and consult physician if irritation or rash develops. Keep out of reach of children. If product is swallowed, get medical attention or contact poison control center immediately.

Adverse Reactions

Not available.

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