Otc - Active Ingredient
Zinc Oxide 14.70%
Whipped Butter Spf 50 Cream
FDA Label NDC 82548-2421
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bloomeffects, Inc for the product Whipped Butter Spf 50 (NDC 82548-2421). 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 otc - active ingredient, otc - purpose, indications & usage, 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
Otc - Purpose
Sunscreen
Indications & Usage
Helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & 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.
Otc - Stop Use
Stop use & ask a doctor if skin rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach from children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
- Apply liberally 15 minutes before sun exposure
- Reapply: after 80 minutes of swimming immediately after towel drying | at least every 2 hours
- limit your time in the sun, especially from 10 a.m - 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
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 value of 15 or higher & other sun protection measures including:
Children under 6 months of age: ask a doctor.
Other Safety Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredient
Octyldodecanol
Caprylic/Capric Triglyceride
Butyloctyl Salicylate
Ethylhexyl Methoxycrylene
C12-15 Alkyl Benzoate
VP/Hexadecane Coplymer
Dibutyl Lauroyl Glutamide
Butrospermum Parkii (Shea) Oil
Rebaudioside-A
Simmondsia Chinensis (Jojoba) Seed Oil
Sodium Hyaluronate
Tetrahexyldecyl Ascorbate
Tocopheryl Acetate
Tulipa Gesneriana Flower Extract
Vitis Vinifera (Grape) Seed Oil
Triethoxycaprylylsilane
Package Label.Principal Display Panel
Whipped Butter Cream Bloomfx (Whippedbuttercreeme)
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