The following Structured Product Label (SPL) was submitted to the FDA by Uniquemi for the product Nubes Sun Block (NDC 84514-0001). 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, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Homosalate 9.00% } ·········································Sunscreen
Octinoxate 6.80% } ···········································Sunscreen
Octisalate 4.50% } ············································Sunscreen
Octocrylene 4.00% } ·········································Sunscreen
Avobenzone 2.70% } ········································Sunscreen
Water, Propanediol, Butyloctyl Salicylate, Benzotriazolyl Dodecyl P-Cresol, Glycerin, Pentylene Glycol, 1,2-Hexanediol, Silica, Dimethicone/Vinyl Dimethicone Crosspolymer, Inulin Lauryl Carbamate, Vp/Eicosene Copolymer, Ammonium Acryloyldimethyltaurate/Vp Copolymer, Xanthan Gum, Ethylhexylglycerin,Iron Oxides(CI 77491), Iron Oxides(CI 77492), Bht, Tocophero
helps prevent sunburn
keep out of reach of the children
• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply: At least 80 minutes after swimming or sweating,
immediately after towel drying, at least every 2 hours.
• For 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, regulary 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.
For extrernal 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 ask a doctor if rash occurs.
Keep out of reach of children. If product is swallowed,
get medical help or contact a Poison Control Center right away.
topical use only
Label (Label)
* Please review the disclaimer below.
