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Drug Facts
Spf 50 Florida Sun Defense Oil
FDA Label NDC 84489-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Naples Soap Company, Inc. for the product Spf 50 Florida Sun Defense (NDC 84489-100). 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 other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Homosalate 10%
Octisalate 5%
Octocrylene 10%
Purpose
Sunscreen
Uses
- Helps prevent sunburn
- lf 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.
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 swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply generously and evenly 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Children under 6 months of age: Ask a doctor
- 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 and other sun protection measures including:
- limit time in the sun, especially from 10 a.m.-2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
Other Information
- Protect the product in this container from excessive heat and direct sun
Inactive Ingredients
Butyloctyl Salicylate, Octyldodecanol, C12-15 Alkyl Benzoate, Polyester-8, Polyamide-3, Lauryl Lactate, Diisopropyl Sebacate, Diethylhexyl Syringylidenemalonate, Tocopherol, Vitis Vinifera (Grape) Seed Oil, Raphanus Sativus (Radish) Seed Extract, Limnanthes Alba (Meadowfoam) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, Camellia Sinensis Extract, Cucumis Sativus (Cucumber) Fruit Extract, Citric Acid
Questions Or Comments?
Call (239) 325-8263 or email [email protected]
Principal Display Panel - 100 Ml Carton Label
NAPLES
SOAP COMPANY
NATURALLY BETTER
SKIN CARE
SPF
50
FLORIDA
SUN DEFENSE
Broad Spectrum SPF 50
Sunscreen
Body Oil
3.4 fl oz / 100 mL
* Please review the disclaimer below.
