FDA.reportPublic FDA data

SPF 50 Sunscreen

Manufacturer
Salt and Stone LLC | Filltech USA, LLC
Effective date
2019-05-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:23:32

Label at a glance#

ProductSPF 50 Sunscreen
Active ingredientZINC OXIDE
Label structure7 sections

Indications and 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.

Dosage and administration

• 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 the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher & other sun protection measures including: • Limit time ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Non-Nano Zinc Oxide 22.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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 the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher & other sun protection measures including:
• Limit time in the sun, especially from 10am - 2pm.
• Wear long-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

• Protect this product from excess heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Helianthus Annuus (Sunflower) Seed Oil*, Cocos Nucifera (Coconut) Oil*, Cera Alba (Beeswax)*,Butyrospermum Parkii (Shea) Butter*, Silica, Copernicia Cerifera (Carnauba) Wax*, Theobroma Cacao (Cocoa) Seed Butter*, Mica, Simmondsia Chinensis (Jojoba) Seed Oil*, Tocopherol (Vitamin E), Iron Oxides. *Organic

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130608473726504GTIN-13: 0608473726504
EAN-13: 0608473726504
GTIN-12: 608473726504
UPC-A: 608473726504
GTIN storage (14 digits): 00608473726504		Label2.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71585-11571585-115-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUNFLOWER OIL3W1JG795YIIACT
COCONUT OILQ9L0O73W7LIACT
YELLOW WAX2ZA36H0S2VIACT
SHEA BUTTERK49155WL9YIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CARNAUBA WAXR12CBM0EIZIACT
COCOA BUTTER512OYT1CRRIACT
MICAV8A1AW0880IACT
JOJOBA OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT
FERRIC OXIDE RED1K09F3G675IACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b6357b60-b975-486f-e053-2a95a90a81d4ed0d3b08-b18a-4925-b537-db45832bf4132020-12-11WarningsExact identifier
spl set id: ed0d3b08-b18a-4925-b537-db45832bf413

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.