Active Ingredient
Active Ingredient: Zinc Oxide
Omega-boost Sheer Mineral Sunscreen Lotion
FDA Label NDC 83105-2001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trilogy Natural Products Limited for the product Omega-boost Sheer Mineral Sunscreen (NDC 83105-2001). 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 active ingredient, uses, warnings, do not use, when using this product, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions) decreases risk of skin cancer and early skin aging caused by the sun
Helps prevent sunburn.
Warnings
- For external use only.
- Do not use on damaged or broken skin
- When using this product [bullet] keep out of eyes. Rinse with water to remove.
- Stop use and ask a doctor if [bullet] rash or irritation develops and lasts.
- Keep out of reach of children, If product is swallowed, get medical help or contact poison control centre right away.
- To ensure compatibility, we recommend patch testing before first use. In the unlikely event of a negative reaction, discontinue use and consult your medical practitioner.
Do Not Use
Do not use on damaged or broken skin
When Using This Product
keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.
Directions
- Apply generously 15 minutes before sun exposure”
- Reapply [bullet] after 80 minutes of swimming or sweating [bullet] immediately after towel drying [bullet] 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 time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredients
Coco-caprylate/caprate, polyglyceryl-3 polyricinoleate, Isostearic acid, Castor oil, Caprilic/capric triglyceride, Coconut oil, Candellila wax, Hydrogenated castor oil, Tocopherol acetate, Rosehip oil, Avocado oil, Fragrance
Other Information
Protect the product in this container from excessive heat and direct sun. Store below 30 degrees celcius.
Trilogy Spf 60+ Omega-Boost Sheer Mineral Sunscreen
NDC 83105-2001-0
Secondary pacakaging
NDC 83105-2001-1
75 mL / 2.5 fl oz
Principal Display Panel:
Inner Container Label
NDC 83105-2001-1
75 mL
Primary Container Label
Sample Size Package
83105-2001-2
5 mL
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