Label: BLUE MONARCH TINTED SPF-50 (ROSE GOLD)- zinc oxide cream
- NDC Code(s): 72101-419-00
- Packager: Blue Monarch, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 11, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Uses:
- Warnings:
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Directions:
- Apply liberally 15 minutes before sun exposure and as needed.
- Children under 6 months of age: ask a doctor.
- Reapply at least every 2 hours
- Use a water-resistant sunscreen if swimming or sweating
- 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: Sun Protection Measures.
- Limit time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
- Other Information:
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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.
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- Package Labeling:
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INGREDIENTS AND APPEARANCE
BLUE MONARCH TINTED SPF-50 (ROSE GOLD)
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72101-419 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 180 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:72101-419-00 1 in 1 BOX 08/07/2023 1 35 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 08/07/2023 Labeler - Blue Monarch, LLC (080991096)
