Otc - Active Ingredient
Active Ingredients Purpose
TItanium Dioxide 3.4% Sunscreen
Zinc Oxide 23.8% Sunscreen
Sunnyscreen Spf 50
FDA Label NDC 75936-250
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 75936-250). 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 liberally and generously 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
- limit your time in the sun, especially from 10
- wear long-sleeved shirts, pants, hats, and sunglasses
- 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:
a.m. – 2 p.m.
Inactive Ingredient
Avena Sativa (Oat) Kernel Flour, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C9-12 Alkane, Caesalpinia Spinosa Gum, Calendula Officinalis Flower Extract, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride,Cetearyl Alcohol,Chamomila Recutita (Matricaria) Flower Extract, Coco-Caprylate/Caprate, Ethylhexylglycerin, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Haematococcus Pluvialis Extract, Helianthus Annuus (Sunflower) Seed Oil, Hydrolyzed Jojoba Esters, Jojoba Esters, Methyl Dihydroabietate, Myrciaria Dubia Fruit Extract, Polyhydroxystearic Acid, Propanediol, Sea Water, Silica, Sodium Phytate, Sorbitan Stearate, Sorbityl Laurate, Stearic Acid, Water
Package Label.Principal Display Panel
Sunnyscreen SPF 50 Lotion for babies+ Kiddos
3 fl. Oz./89ml
* Please review the disclaimer below.
