Otc - Active Ingredient
Active Ingredients Purpose
TItanium Dioxide 2.3% Sunscreen
Zinc Oxide 17.9% Sunscreen
100% Mineral Broad Spectrum Sunscreen Spf 50 Lotion
FDA Label NDC 75936-362
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 100% Mineral Broad Spectrum Sunscreen Spf 50 (NDC 75936-362). 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 skincancer and early skin aging caused by the sun
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
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.
- If product is swallowed, get medical help or contact a Poison Control right away.
Dosage & Administration
Directions
- apply generously and evenly 15 minutes before sun exposure
- after80 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 sub and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m.- 2 p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses
- Children under 6 months: Ask a doctor
reapply
Inactive Ingredient
Inactive Ingredients Arachidyl Alcohol, Arachidyl Glucoside, Astrocaryum Vulgare Kernel Oil, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, C13-14 Alkane, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucosde, Diheptyl Succinate, Erythritol, Ethyl Ferulate, Glycerin, Haematococcus Pluvialis Extract, Jojoba Esters, Lauryl Laurate, Methyl dihydroabietate, Microcrystalline Cellulose, Neopentyl Glycol Diheptanoate, Polyester-7, Polyester-8, Polyhydroxystearic Acid, Propanediol, Sea Water, Sodium Gluconate, Sodium Stearoyl Glutamate, Tocopherol, Water
Package Label.Principal Display Panel
Supergoop!
PLAY
SPF 50
100% Mineral Lotion
With Green Algae
Broad Spectrum Sunscreen SPF 50 PA++++
Water resistant (80 minutes)
3.4 fl. oz. / 100 ml.
* Please review the disclaimer below.
