Otc - Active Ingredient
Active Ingredients Purpose
Zinc Oxide 21% Sunscreen
Sunnyscreen Spf 50 Stick
FDA Label NDC 75936-251
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Supergoop, Llc for the product Sunnyscreen Spf 50 Stick (NDC 75936-251). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, 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
Uses
- Helps Prevent Sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
If product is swallowed, get medical help or contact a poison Control Center right away
Indications & Usage
Stop use and ask a doctor if rash occurs or irritation develops and lasts.
Warnings
Warnings
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove
For external use only
Dosage & Administration
Directions
• Apply generously and evenly 15 minutes before sun exposure and at least
every 2 hours.
• Reapply:
• after 80 minutes of swimming or sweating • immediately after towel drying
• at least every 2 hours.
•
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 your time in the sun, especially from 10
a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months of age: ask a doctor.
Inactive Ingredient
Inactive Ingredients Beeswax, Bertholletia Excelsa Seed Oil, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea Butter), Euphorbia Cerifera (Candelilla) Wax, Heptyl Undecylenate, Linum Usitassimum (Lineseed) Oil, Olea Europaea (Olive) Fruit Extract, Olea Europaea (Olive) Fruit Oil, Oryzanol, Salvia hispanica (Chia) Seed Oil, SImmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao(Cocoa) Seed Butter, Tocopherol, Triethyl Citrate, Vanilla Planifolia Fruit Extract
Package Label.Principal Display Panel
Sunnyscreen
SPF 50 Stick for babies + kiddos
Broad Spectrum Sunscreen SPF 50
Water Resistant (80 minutes)
0.7 oz. / 19.8g
* Please review the disclaimer below.
