Otc - Active Ingredient
Zinc Oxide 15.6% ... Sunscreen
Sunplus Sunscreen Yosemite Spf 45
FDA Label NDC 65112-264
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 Yosemite Spf 45 (NDC 65112-264). 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, indications & usage, inactive ingredient, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
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.
Indications & Usage
Helps prevent sunburn
If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early aging caused by the sun.
Inactive Ingredient
Purified Water, Coco-Caprylate/Caprate(and)Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Glycerin, Butylene Glycol, Acetyl Tyrosine, Hydrolyzed Vegetable Protein, Adenosine Triphosphate, Riboflavin, Butyrospermum Parkii Butter, Hippophae Rhamnoides Seed Oil, Terminalia Ferdinandiana Seed Oil, Caryodendron Orinocense Seed Oil, Palmitic Acid, Stearic Acid, Calophyllum Tacamahaca Seed Oil, Orbignya Oleifera Seed Oil, Cocos Nucifera Oil, Theobroma Grandiflorum Seed Butter, Astrocaryum Murumuru Seed Butter, Gardenia Taitensis Flower Extract, Tocopherol, Hippophae Rhamnoides Fruit Oil, Cetearyl Alcohol, Ceteareth 20, Glyceryl Stearate, PEG-100 Stearate, Isononyl Isononoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Polysorbate 60, Ethylhexyl Palmitate, Cetyl Alcohol, Isoamyl Stearate, Bisabolol, Glycine Soja Oil, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethiconol, Phenoxyethanol, Ethylhexylglycerin, Fragrance.
Dosage & Administration
- Apply liberally and evenly 15 minutes before sun exposure.
- 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 am - 2 pm.
-- Wear long-sleeved shirts, pants, hats, and sunglasses
-- Reapply after 80 minutes of swimming or seating:
---- Immediately after towel drying
---- At least every 2 hours
* Please review the disclaimer below.
