Otc - Active Ingredient
ZINC OXIDE 9.75%, OCTINOXATE 7.5%, OCTISALATE 5%
Sunplus Sunscreen Laguna
FDA Label NDC 65112-263
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by I Shay Cosmetics Inc for the product Sunplus Sunscreen Laguna (NDC 65112-263). 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, warnings, inactive ingredient, dosage & administration, storage and handling, other safety information, label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Helps prevent sunburn and photodamage - If used as directed with other sun protection measures (See Directions). decreases the risks of skin cancer and early aging caused by the sun.
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 ask a doctor if rash occurs.
If swallowed, get medical help or contact poison control center
Keep out of reach of children
Inactive Ingredient
Purified Water, Capric/Caprylic, Glycerin, Cetearyl Alcohol, Ceteareth-20, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethilconol, Potassium Cetyl Phosphate, Glyceryl Stearate, PEG-100 Stearate, Acrylate Copolymer, Phenoxyethanol, Ethylhexylglycerin, Helianthus annuus (Sunflower) Seed Oil, Carthamus tinctorius (Safflower) Seed Oil, Vitis vinifera (Grape) Seed Oil, Allantoin, Hyaluronic acid, Oenothera Biennis (Evening Primrose) Borago officinalis (Starflower) Oil, Rubus idaeus (Red Raspberry) Seed Oil, Bisobolol (Chamomile)
Dosage & Administration
Apply liberally to dry skin 15 minutes before sun exposure *Reapply to dry skin after 80 minutes of swimming or sweating *immediately after towel drying * at least every 2 hours * Children under 6 months ask a doctor
Storage And Handling
OTHER iNFORMATION Protect the product in this container from excessive heat and direct sun.
Other Safety Information
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 10a.m. – 2 p.m. * Wear long-sleeved shirts, pants, hats, and sunglasses
Label
Label (Laguna1)
* Please review the disclaimer below.
