FDA.reportPublic FDA data

Solvyn Mineral Sunscreen SPF 50

Manufacturer
Solvyn Skin LLC | Pure Source, LLC
Effective date
2026-06-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-15 00:32:43

Label at a glance#

ProductSolvyn Mineral Sunscreen SPF 50
Active ingredientZINC OXIDE
Label structure8 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 and as needed. Children under 6 months of age: ask a doctor. 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 broad spectrum SPF of 15 or higher and other ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 17.50 %

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 if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Adansonia Digitata Oil, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Cetearyl Glucoside, C12-15 Alkyl Benzoate, Citric Acid, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Decyl Glucoside, Daucus Carota Sativa (Carrot) Seed Extract, Dodecane, Glyceryl Caprylate, Glyceryl Stearate SE, Glyceryl Undecylenate, Glycerin, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Propanediol, Punica Granatum Fruit Extract, Sodium Stearoyl Glutamate, Stearic Acid, Tocopherol, Tridecyl Salicylate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Water (Aqua), Xanthan Gum

Questions?

OTC - QUESTIONS SECTION

(305) 209-8451

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87777-94887777-948-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARIC ACID4ELV7Z65APIACT
TOCOPHEROLR0ZB2556P8IACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZACTIM
ADANSONIA DIGITATA SEED OIL77MKL7AR5IIACT
ALOE VERA LEAFZY81Z83H0XIACT
SHEA BUTTERK49155WL9YIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SAFFLOWER OIL65UEH262ISIACT
COCONUT OILQ9L0O73W7LIACT
CUCUMBERYY7C30VXJTIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
DAUCUS CAROTA SUBSP. SATIVUS SEED9M6AAX381UIACT
DODECANE11A386X1QHIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
GLYCERINPDC6A3C0OXIACT
AVOCADO OIL6VNO72PFC1IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PROPANEDIOL5965N8W85TIACT
POMEGRANATE56687D1Z4DIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT

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
Solvyn Mineral Sunscreen SPF 50ZINC OXIDESolvyn Skin LLCb0a8d028-87d2-4339-8879-c62cbf8415f22026-06-15WarningsExact identifier
ndc (package): 87777-948-00
ndc (product): 87777-948
ndc11 (package): 87777094800
spl id: 544a3dd6-2eaf-0bdd-e063-6294a90a940d
spl set id: b0a8d028-87d2-4339-8879-c62cbf8415f2

Reported adverse events (FAERS/openFDA)#

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