SPL UNCLASSIFIED SECTION
DRUG FACTS
DRUG FACTS
Active Ingredients
Zinc Oxide @ 20%
Purpose
Sunscreen
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.
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.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children.
If product is swallowed, get medical help or
contact a Poison Control Center right away.
Directions
• apply liberally 15 minutes before sun exposure.
• reapply: • after swimming or excessive sweating;
• at least every 2 hours; • immediately after towel drying.
• children under 6 months, consult 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. to 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
Other Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Water/Aqua, *Simmondsia Chinensis (Jojoba) Seed Oil, *Carthamus
Tinctorius (Safflower) Seed Oil, *Glycerin, Cetearyl Olivate, Squalane,
Lactic Acid, Sorbitan Olivate, Lactobacillus Ferment, *Aloe Barbadensis
Leaf Juice, *Cocos Nucifera (Coconut) Oil, Pelargonium Graveolens
Flower Oil, Polyhydroxystearic Acid, Sodium Levulinate, Xanthan Gum,
Potassium Sorbate, Helianthus Annuus (Sunflower) Seed Wax, Ascorbyl
Palmitate, Tocopherol
*certified organic
Retail Package
Bottle
rege
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 54111-140 | 54111-140-50 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 6f8f58e9-69a3-4d52-b9ff-900083468b46 | 53cb4b65-ba1d-4f7d-94bb-6d29b5ceb429 | 2022-02-13 | Warnings | 53cb4b65-ba1d-4f7d-94bb-6d29b5ceb429 |
Adverse event summaries are temporarily unavailable. Other product information remains available.