Otc - Active Ingredient
Avobenzone 2.9%..............Sunscreen
Homosalate 9.8%.............Sunscreen
Octisalate 4.9%..................Sunscreen
Octocrylene 9.5%...............Sunscreen
Defense Refresh (re)setting Mist Spf 40 Liquid
FDA Label NDC 75936-354
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 Defense Refresh (re)setting Mist Spf 40 (NDC 75936-354). 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
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 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 useon damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove.
Dosage & Administration
· Shake well then 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 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
Alcohol Denat., Bisabolol, Brassica Campestris/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, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Caprylyl Silylate
Other Safety Information
Protect the product in this contianer from excessive heat and direct sun.
Package Label.Principal Display Panel
Supergoop!
Defense Refresh
(RE) Setting Mist
SPF 40
Broad Spectrum Sunscreen SFP 40
Water & Sweat Resistant (40 minutes)
1.0 fl. oz. / 30 ml.
* Please review the disclaimer below.
