FDA.reportPublic FDA data

Solthera SPF-30 Cream

Manufacturer
Markey Products, LLC
Effective date
2018-06-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:53:53

Label at a glance#

ProductSolthera SPF 30
Active ingredientTITANIUM DIOXIDE, ZINC 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:            - At least every two-hours.            - Immediately after swimming, sweating or towel drying. SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection me...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 6.00%

Zinc Oxide 6.00%

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 consult physician

OTC - STOP USE SECTION

if irritation or rash develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical attention or contact poison control center immediately.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15-minutes before sun exposure.
  • Reapply:

           - At least every two-hours.

           - Immediately after swimming, sweating or towel drying.

SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:

           - Limit time in the sun, especially between 10am and 2pm.

           - Wear long sleeve shirts, pants, hats and sunglasses.

           - For children under 6-months, consult a physician.

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Citric Acid, Cocos Nucifera (Coconut) Oil, Dehydroxanthan Gum, Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Hemp Seed Oil, Lecithin, Mangifera Indica (Mango) Seed Butter, Sodium Benzoate, Sodium Laurylglucosides Hydroxypropyl Sulfonate, Styrene/Acrylates Copolymer, Tocopherol Acetate (Vitamin E), Xanthan Gum, Coconut-Derived Natural Fragrance.

Other Information:

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sunlight.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130867823000415GTIN-13: 0867823000415
EAN-13: 0867823000415
GTIN-12: 867823000415
UPC-A: 867823000415
GTIN storage (14 digits): 00867823000415		Label.jpg

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71434-35271434-352-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCONUT OILQ9L0O73W7LIACT
DEHYDROXANTHAN GUM63ZP7I1BQOIACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERINPDC6A3C0OXIACT
SOYBEAN OIL241ATL177AIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
SODIUM BENZOATEOJ245FE5EUIACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
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
074bb33f-2116-157a-e063-6294a90a0ec459e70491-ca2f-4051-bf0a-0e5394302fa92023-10-09WarningsExact identifier
spl set id: 59e70491-ca2f-4051-bf0a-0e5394302fa9

Reported adverse events (FAERS/openFDA)#

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