Otc - Active Ingredient
Active Ingredients
Zinc Oxide 25%
Sunclear
FDA Label NDC 42387-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Grahams Natural Alternatives Pty Ltd for the product Sunclear (NDC 42387-001). 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, dosage & administration, warnings, description, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
sunscreen
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. If swallowed, get medical help or contact a poison control center immediately.
Indications & Usage
Uses
helps prevent sunburn
Dosage & Administration
Directions
apply liberally 15 minutes before sun exposure
reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- children under 6 months: ask a doctor
Warnings
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
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.
Stop use and ask a doctor if rash occurs
Description
Reef Friendly
Non Nano
SunClear SPF 30 sunscreen
UVA & UVB
Broad Spectrum Protection
Very Water Resistant
80 minutes
Sensitive Skin Formula
Thank you for choosing our premium eco friendly Sunscreen.
It is tried and tested under the harsh conditions of the Australian sun! Especially formulated for those with sensitive skin and all skin types.
SunClear Natural sunscreen is the perfect sunblock that will not harm you, the water, the earth or the coral reefs!
Otc - Questions
Other Information
protect this product from excessive heat and direct sun
Questions www.itchy.net.au
Made in Australia
Grahams Natural Alternatives Pty Ltd
7 Palings Court, Nerang, QLD 4211 Australia
Inactive Ingredient
Inactive Ingredients
caprylic/capric trilglyceride, rosa canina seed (rose hip) oil, vitis vinifera seed (grape seed) oil, olea europaea (extra virgin olive) oil, sesamum indicum (sesame) oil, butyspermum parkii (shea) butter, tocopherol (natural vitamin E), provitamin A, phenoxyethanol, coconut oil.
* Please review the disclaimer below.
