FDA.reportPublic FDA data

MIRABELLA Broad Spectrum SPF 30 Sunscreen

Manufacturer
GDM ENTERPRISES LLC
Effective date
2024-05-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:02

Label at a glance#

ProductMIRABELLA Broad Spectrum SPF 30 Sunscreen
Active ingredientHOMOSALATE, OCTISALATE, AVOBENZONE
Label structure8 sections

Indications and uses

helps prevent sunburn higher SPF gives more sun protection retains SPF after 80 minutes of swimming or sweating 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 this risk, regulary use a sunscreen with broad spectrum SPF of 15 or higher and other...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10.00%
Octisalate 5.00%
Avobenzone 3.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • higher SPF gives more sun protection
  • retains SPF after 80 minutes of swimming or sweating
  • 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 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 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 this risk, regulary 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

Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Beta-Carotene, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic Capric, Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Citrullus Lanatus (Watermelon Extract, Daucus Carota Sativa (Carrot) Extract, Dimethicone, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Seed Oil, Hyaluronic Acid, Isododecane, C13-14 Isoparaffin, Laureth-7, Magnesium Aluminum Silicate, Polyacrylamide, Polyhydroxystearic Acide, Polysorbate-20, Rosmarinus Officinalis (Rosemary) Extract, Saccharide Isomerate, Sodium Stearoyl Glutamate, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Trimethylsiloxysilicate, Xanthan Gum.

Questions?

OTC - QUESTIONS SECTION

(661) 702-9910

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer LabelOuter LabelInner LabelInner Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83741-480-00MIRABELLA Broad Spectrum SPF 30 Sunscreen1 in 1 BOXCREAM11
83741-480-00MIRABELLA Broad Spectrum SPF 30 Sunscreen40 mL in 1 BOTTLE, PUMPCREAM401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83741-480MIRABELLA BROAD SPECTRUM SPF 30 SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE) CREAM [GDM ENTERPRISES LLC]1Current NDC, 2 package rows20240507_3ac847d5-a75d-4b32-84e1-70e4282c0d72.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83741-48083741-480-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ASCORBYL PALMITATEQN83US2B0NIACT
BETA CAROTENE01YAE03M7JIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATERMELON231473QB6RIACT
CARROTL56Z1JK48BIACT
DIMETHICONE92RU3N3Y1OIACT
DODECANE11A386X1QHIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL LAURATEY98611C087IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SUNFLOWER OIL3W1JG795YIIACT
HYALURONIC ACIDS270N0TRQYIACT
ISODODECANEA8289P68Y2IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
POLYSORBATE 207T1F30V5YHIACT
ROSEMARYIJ67X351P9IACT
SACCHARIDE ISOMERATEW8K377W98IIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
STEARYL ALCOHOL2KR89I4H1YIACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB

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
MIRABELLA Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTISALATE, AVOBENZONEGDM ENTERPRISES LLC3ac847d5-a75d-4b32-84e1-70e4282c0d722024-05-06WarningsExact identifier
ndc (package): 83741-480-00
ndc (product): 83741-480
ndc11 (package): 83741048000
spl id: 17c8c23c-4be5-8d00-e063-6394a90a941b
spl set id: 3ac847d5-a75d-4b32-84e1-70e4282c0d72

Reported adverse events (FAERS/openFDA)#

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