FDA.reportPublic FDA data

BELASOL Sun Cream Non-Tinted Moisturizing SPF 50

Manufacturer
EK Clothing LLC dba Belasol
Effective date
2023-11-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:02:27

Label at a glance#

ProductBELASOL Sun Cream Non-Tinted Moisturizing SPF 50
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn. Higher SPF gives more sunburn protection. Retains SPF after 40 minutes of swimming or sweating. If used as directed with other sun protection measures (see Directions ), decrease 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 40 minutes of swimming or sweating. Imediately 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 oth...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanuium Dioxide 2.00%

Zinc Oxide 17.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Retains SPF after 40 minutes of swimming or sweating.
  • If used as directed with other sun protection measures (see Directions), decrease 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.

If pregnant or breast-feeding, 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 40 minutes of swimming or sweating.
  • Imediately 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

Aqua (Deionized Water), Butyloctyl salicylate, Camelllia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citric Acid, Caprylyl Glycol, Cocos Nucifera (Coconut) Oil, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hydrogenated Methyl Abietate, Iron Oxides (Black, Red, Yellow), Isododecane, Polyhydroxystearic Acid, Polysilicone-15, Polysorbate-20, Punica Granatum (Pomegranate) Extract, Squalane, Stearic Acid, Tetrahexyldecyl Ascorbate (Vitamin C), Trimethylsiloxysilicate, Ubiquinone (CoQ10), Xanthan Gum, Zemea (Corn) Propanediol.

Questions?

OTC - QUESTIONS SECTION

(786) 361-7266

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83789-434-00BELASOL Sun Cream Non-Tinted Moisturizing SPF 50118.3 mL in 1 TUBECREAM118.31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83789-434BELASOL SUN CREAM NON-TINTED MOISTURIZING SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [EK CLOTHING LLC DBA BELASOL]1Current NDC, 1 package rows20231120_fb677ad0-2791-44ec-9720-951471ec009a.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83789-43483789-434-00

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
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CAPRYLYL GLYCOL00YIU5438UIACT
COCONUT OILQ9L0O73W7LIACT
DODECANE11A386X1QHIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL LAURATEY98611C087IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
HYDROGENATED METHYL ABIETATEA23O709X8OIACT
FERRIC OXIDE RED1K09F3G675IACT
ISODODECANEA8289P68Y2IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYSILICONE-15F8DRP5BB29IACT
POLYSORBATE 207T1F30V5YHIACT
PUNICA GRANATUM ROOT BARKCLV24I3T1DIACT
SQUALANEGW89575KF9IACT
STEARIC ACID4ELV7Z65APIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
UBIDECARENONEEJ27X76M46IACT
XANTHAN GUMTTV12P4NEEIACT
CORN0N8672707OIACT
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
BELASOL Sun Cream Non-Tinted Moisturizing SPF 50TITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasolfb677ad0-2791-44ec-9720-951471ec009a2023-11-09WarningsExact identifier
ndc (package): 83789-434-00
ndc (product): 83789-434
ndc11 (package): 83789043400
spl id: 09b53878-59e1-2326-e063-6294a90aa3a4
spl set id: fb677ad0-2791-44ec-9720-951471ec009a

Reported adverse events (FAERS/openFDA)#

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