BLUE MONARCH SPF-30- titanium dioxide, zinc oxide cream

Blue Monarch SPF-30 by

Drug Labeling and Warnings

Blue Monarch SPF-30 by is a Otc medication manufactured, distributed, or labeled by Blue Monarch, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENTS

Titanium dioxide 6%

Zinc oxide 6%

Purpose

Sunburn Protection

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.

WARNINGS

For external use only.

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and consult physician if

irritation or rash develops.

Keep out of reach of children.

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

DIRECTIONS

• 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

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

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

INGREDIENTS AND APPEARANCE

BLUE MONARCH SPF-30 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72101-160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARROT (UNII: L56Z1JK48B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN OIL (UNII: 241ATL177A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALMOND OIL (UNII: 66YXD4DKO9)
SESAME OIL (UNII: QX10HYY4QV)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72101-160-04	1 in 1 BOX	02/01/2018
1		120 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2018

Labeler - Blue Monarch, LLC (080991096)