Otc - Active Ingredient
Active ingredients Purpose
Avobenzone 2.9% Sunscreen
Homosalate 9.8% Sunscreen
Octisalate 4.9% Sunscreen
Octocrylene 9.5% Sunscreen
(re)setting Refreshing Mist Spf 40 Spray
FDA Label NDC 75936-361
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 (re)setting Refreshing Mist Spf 40 (NDC 75936-361). 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
- 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
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
- Apply generously and evenly 15 minutes before sun exposure
- reapply:
- after 40 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:
Alcohol Denat., Bisabolol, Brassica Camprestris/Aleurites Fordi Oil Copolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Dicaprylyl Carbonate, Diethylhexyl Syringylidenemalonate, Diheptyl Succinate, Diisooctyl Succinate, Ethyl Ferulate, Isododecane, Lauroyl Lysine, Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Nylon-12, PVP, Rosemarinus Officinalis (Rosemary) Leaf Oil, Silica Caprylyl Silylate
Package Label.Principal Display Panel
Supergoop!
(Re) Setting Refreshing Mist
SPF 40
Broad Spectrum
Sunscreen SPF 40 PA+++
Water & Sweat Resistant (40 minutes)
3.4 fl. oz. / 100 ml.
* Please review the disclaimer below.
