Otc - Active Ingredient
Active Ingredient Purpose
Titanium Dioxide 10% Sunscreen
Zinc Oxide 12% Sunscreen
Sunnyscreen Spf 50
FDA Label NDC 75936-252
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 (NDC 75936-252). 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
Warnings
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.
Dosage & Administration
Directions
- Apply generously and evenly 15 minutes before sun exposure
- 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
- Children under 6 months of age: ask a doctor.
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
Inactive Ingredient
Inactive Ingredients
Aqua (Deionized water), Ascorbyl Palmitate, Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Capryl/Caprylyl Glucoside, Chamomilla Recutita (Chamomile) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Mangifera Indica (Mango) Butter, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.
Package Label.Principal Display Panel
Supergoop
Sunnyscreen SPF 50 spray for babies + kiddos
Broad Spectrum Sunscreen SPF 50
Water Resistant (80 minutes)
3.4 fl oz./100 ml
* Please review the disclaimer below.
