Otc - Active Ingredient
Active Ingredients:
Octinoxate - 7.50%
Octisalate - 5.00%
Oxybenzone - 3.00%
Hampton Sun
FDA Label NDC 87170-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hampton Sun for the product Hampton Sun (NDC 87170-002). 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 - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Octinoxate - 7.50% .....................Sunscreen.
Octisalate - 5.00% ......................Sunscreen.
Oxybenzone - 3.00% ..................Sunscre.en.
Indications & Usage
Use • helps prevent sunburn.
Warnings
Warnings
Skin cancer/Skin Aging alert
For external use only
Do noy use on Damage or broken skin
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 immediately.
Dosage & Administration
DIRECTIONS
• Apply liberally 15 minutes before sun exposure.
•Use a water resistant sunscreen if swimming or sweating.
•Reapply at least every 2 hours
•Children under 6 months of age: ask a doctor.
Inactive Ingredient
Inactive Ingredients:
Aloe Barbadensis Leaf Extract, Benzotriazolyl Dodecyl p-Cresol, C12-15 Alkyl Benzoate, Cyclohexasiloxanel, Cyclopentasiloxane
Dimethicone Crosspolymer, Fragrance, Hydrogenated Polyisobutene, Hydrolyzed Jojoba Esters, Jojoba Esters, Juglans Regia (Walnut) Seed Oil, Mineral OilSorbitan Olivate, Tocopheryl Acetatel, Water
Package Label.Principal Display Panel
Spf 8 Gel (2019 06 01 085923)
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