Otc - Active Ingredient
Ttianium Dioxide 23% ..............Sunscreen
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick Spf 35 Coolangatta Beige Stick
FDA Label NDC 66990-1025
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Toshiki Pigment Co., Ltd. for the product Vertra Mick Fanning Signature Foundation Sunscreen Face Stick Spf 35 Coolangatta Beige (NDC 66990-1025). 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, storage and handling, 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.
- Higher SPF gives more sunburn protection.
- Retains SPF after 80 minutes activity in the water, sweating or perspiring.
- Provides high protection against sunburn.
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 or irritation develops and lasts.
Warnings
Do not use:
- On damaged or broken skin
- Keep out of eyes. Rinse with water to remove.
When using this product:
For external use only.
Dosage & Administration
- Apply liberally and generously 15 minutes before sun exposure and at least every 2 hours.
- Children under 6 months of age: ask a doctor.
- 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
- Reapply:
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
Inactive Ingredient
Hexyldecyl Isostearate, Aluminum Hydroxide, Mica, Iron Oxides, Stearic Acid, Paraffin, Ozokerite, Synthetic Wax, Ethylene/Propylene Copolymer, Polyglyceryl-2 Oleate, Tocopherol, Stearyl Glycyrrhetinate, Fragrance
Storage And Handling
- Protect this product in this contianer from excessive heat and direct sun.
Package Label.Principal Display Panel
VERTA
PREMIUM SUNCARE
SPF 35
Premium Mineral Based
Foundation Sunscreen Face Stick
Reef Safe
Broad Spectrum SPF35
Water Resistant (80 Minutes)
Color: Coolangatta Beige
11g NET WT. 0.39 OZ
* Please review the disclaimer below.
