Otc - Active Ingredient
Active Ingredients Purpose
Zinc Oxide 15.7% Sunscreen
Ounce By Ounce Broad Spectrum Sunscreen Spf 30
FDA Label NDC 75936-158
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 Ounce By Ounce Broad Spectrum Sunscreen Spf 30 (NDC 75936-158). 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, other safety information, 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 at least every 2 hours
- wear a water resistant sunscreen if swimming or sweating.
- 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 value of 15 or higher 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
Inactive Ingredient
Inactive Ingredient Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Calcium Sodium Borosilicate, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cetearyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Glycerin, Sodium Gluconate, Sodium Stearoyl Glutamate, Tetradecane, Tocopherol, Water, Xanthan Gum
Other Safety Information
Other Information Protect the product in this container from excessive heat and direct sun
Package Label.Principal Display Panel
Ounce by Ounce
Supergoop
SPF 30 Lotion
100% Non-nano Mineral
Broad Spectrum Sunscreen SPF 30
18 fl. oz. / 532 ml.
* Please review the disclaimer below.
