Blue Monarch SPF-30 Cream

Manufacturer
Blue Monarch, LLC
Effective date
2018-02-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:03:28

Label at a glance#

ProductBlue Monarch 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 2 hours. Immediately after swimming, sweating or towel drying. Do not store in excessive heat or direct sunlight.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 6%

Zinc oxide 6%

Purpose

OTC - PURPOSE SECTION

Sunburn Protection

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 if

OTC - STOP USE SECTION

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 2 hours.
  • Immediately after swimming, sweating or towel drying.
  • Do not store in excessive heat or direct sunlight.

SUN PROTECTION MEASURES

SPL UNCLASSIFIED SECTION

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.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf (aloe vera gel) juice, aqua (deionized water), camellia sinensis (green tea) extract, daucus carota sativa (carrot) extract, ethylhexylglycerin, ethylhexyl palmitate, glycerin, glycine soja (soybean) oil, helianthus annuus (sunflower) oil, lecithin, phenoxyethanol, prunus amygdalus dulcis (sweet almond) oil, sesamum indicum (sesame) seed oil, sodium laurylglucosides hydroxypropylsulfonate, theobroma cacao (cocoa) butter, tocopherol (vitaminE), xanthan gum.

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blue MonarchBlue Monarch

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72101-16072101-160-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
071ddf7f-16b4-10a9-e063-6394a90a6af49a9b26eb-185a-4c68-819d-8a4fe0df093a2023-10-07WarningsExact identifier
spl set id: 9a9b26eb-185a-4c68-819d-8a4fe0df093a

Reported adverse events (FAERS/openFDA)#

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