Otc - Active Ingredient
Active ingredients purpose
Zinc Oxide 25%.....Sunscreen
Sheer Guard Natural Mineral Sunscreen Broad Spectrum Spf 50 Cream
FDA Label NDC 70157-028
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Baxter Laboratories Pty for the product Sheer Guard Natural Mineral Sunscreen Broad Spectrum Spf 50 (NDC 70157-028). 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. 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 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
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
- 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 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10a.m. – 2p.m.
- Wear long-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
Inactive Ingredient
Inactive ingredients
Water, Isohexadecane, Isopropyl Palmitate, Butyloctyl Salicylate, Polyglyceryl-2 Dipolyhydroxstearate, Polyglyceryl-3 Diisostearate, Isododecane, Magnesium Sulfate, Disteardimonium Hectorite, Polyhydroxystearic Acid, Stearic Acid, Phenoxyethanol, Benzyl Alcohol, Citric Acid, Glyceryl Behenate, Caprylyl Glycol, Propylene Carbonate, Sorbic Acid, Panthenol, Sodium Hyaluronate, Simmondsia Chinenesis (Jojoba) Seed Oil
Package Label.Principal Display Panel
Everyday Humans
SPF 50
Sheer Guard Natural Mineral Suunscreen
with pro-vitamin B5
Broad Spectrum UVA/UVB
Water Resistant (80 minutes)
Net Wt. 3.4 OZ 100G
* Please review the disclaimer below.
