BLUE MONARCH TINTED SPF-50 (ROSE GOLD)- zinc oxide cream 
Blue Monarch, LLC

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BLUE MONARCH Tinted SPF-50 (Rose Gold)

Drug Facts

Active Ingredients

Zinc Oxide 18.00%

Purpose

Sunscreen

Uses:

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 ask a doctor if

  • rash or irritation developsand

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use

Directions:

Other Information:

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, C18-21 Alkane, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Iron Oxides (Black, Red, Yellow), Mangifera lndica (Mango) Butter, Punica Granatum (Pomegranate) Extract, Ricinus Communis (Castor) Oil, Sorbitan Stearate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Vaccinium Angustifolium (Blueberry) Extract, Xanthan Gum, Zemea (Corn) Propanediol.

Questions?

(617) 943-0951

Package Labeling:

LabelLabel2

BLUE MONARCH TINTED SPF-50 (ROSE GOLD) 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72101-419
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION180 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
SHEA BUTTER (UNII: K49155WL9Y)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
C18-C21 ALKANE (UNII: 33822S0M40)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATERMELON (UNII: 231473QB6R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
DODECANE (UNII: 11A386X1QH)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL LAURATE (UNII: Y98611C087)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MANGO (UNII: I629I3NR86)  
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
CASTOR OIL (UNII: D5340Y2I9G)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BLUEBERRY (UNII: 253RUG1X1A)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CORN (UNII: 0N8672707O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72101-419-001 in 1 BOX08/07/2023
135 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/07/2023
Labeler - Blue Monarch, LLC (080991096)

Revised: 11/2023
Document Id: 09dc64a4-8580-ddca-e063-6294a90ab8f1
Set id: 9ba00a03-1015-4946-8c9b-5ef377a32e4b
Version: 2
Effective Time: 20231111
 
Blue Monarch, LLC