Label: BLUEVADO SUNFIX- zinc oxide, titanium dioxide lotion
- NDC Code(s): 77358-201-03
- Packager: Magic Blue, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 11, 2024
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- Active Ingredients
- Purpose
- Uses
- Warnings:
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Directions:
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- Apply liberally 15 minutes before sun exposure
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- Reapply: after 40 minutes of swimming or sweating; immediately after towel drying; at least every 2 hours
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
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- Limit time in the sun, especially from 10 a.m. – 2 p.m.
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- Wear long sleeves shirts, pants, hats, and sunglasses
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- Children under 6 months: Ask a physician.
- Other Information:
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Inactive Ingredients:
Argania Spinosa (Argan) Kernel Oil, Ascorbyl Palmitate, Bisabolol Butyrospermum Parkii (Shea) Butter, C13-15 Alkane, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Alcohol, Cetyl Alcohol, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Citrus Grandis (Grapefruit) Peel Oil, Cocos Nucifera (Coconut) Oil, Glycerin, Glyceryl Stearate, Heptyl Undecylenate, Jojoba Esters, Lavandula Angustifolia (Lavender) Oil, Methylene Blue, Oryza Sativa (Rice) Bran Oil, PEG-100 Stearate, Pelargonium Graveolens (Geranium) Leaf Oil, Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 60, Sorbitan Laurate, Tocopheryl Acetate, Water (Aqua), Xanthan Gum.
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INGREDIENTS AND APPEARANCE
BLUEVADO SUNFIX
zinc oxide, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77358-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8.2 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.8 g in 100 mL Inactive Ingredients Ingredient Name Strength ARGAN OIL (UNII: 4V59G5UW9X) ASCORBYL PALMITATE (UNII: QN83US2B0N) LEVOMENOL (UNII: 24WE03BX2T) SHEA BUTTER (UNII: K49155WL9Y) C13-15 ALKANE (UNII: 114P5I43UJ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) BERGAMOT OIL (UNII: 39W1PKE3JI) CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44) COCONUT OIL (UNII: Q9L0O73W7L) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HEPTYL UNDECYLENATE (UNII: W77QUB6GXO) LAVENDER OIL (UNII: ZBP1YXW0H8) METHYLENE BLUE (UNII: T42P99266K) RICE BRAN OIL (UNII: LZO6K1506A) PEG-100 STEARATE (UNII: YD01N1999R) GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 60 (UNII: CAL22UVI4M) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77358-201-03 90 mL in 1 TUBE; Type 0: Not a Combination Product 12/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 12/01/2021 Labeler - Magic Blue, LLC (114903371) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing, Inc. 793406000 MANUFACTURE(77358-201)
