Otc - Active Ingredient
Active Ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 4% Sunscreen
Octinoxate 6% Sunscreen
Octisalate 3% Sunscreen
Defense Refresh Settingh Mist Broad Spectrum Sunscreen Spf 50
FDA Label NDC 75936-133
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Taylor James, Ltd for the product Defense Refresh Settingh Mist Broad Spectrum Sunscreen Spf 50 (NDC 75936-133). 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
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 swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
Directions Apply 15 minutes prior to sun exposure
Use a water resistant if swimming or sweating
Reapply at least every 2 hours
Children under 6 months: Ask a doctor
Inactive Ingredient
Inactive Ingredients Alcohol Denat., Caprylic Capric Triglyceride, Dicaprylyl Carbonate, Isododecane, Mentha Piperita (Peppermint) Stem/leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate, WaterInactive Ingredients Alcohol Denat., Caprylic Capric Triglyceride, Dicaprylyl Carbonate, Isododecane, Mentha Piperita (Peppermint) Stem/leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate, WaterInactive Ingredients Alcohol Denat., Caprylic Capric Triglyceride, Dicaprylyl Carbonate, Isododecane, Mentha Piperita (Peppermint) Stem/leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate, Water
Package Label.Principal Display Panel
Defense Refresh Setting Mist
With Rosemary
Broad Spectrum Sunscreen SPF 50
Matte finish three in one
sets make-up, controls oil and delivers UV photoaging protection
Label (Overlabel)
Box (Box)
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