Label: NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS ILLUMINATING 40ML WITH PINK ALGAE SPF 50- titanium oxide, zinc oxide liquid

  • NDC Code(s): 62282-986-01, 62282-986-02, 62282-986-03
  • Packager: Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 3, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    Active Ingredients:
    Titanium Dioxide 3.3%
    Zinc Oxide 14.9%

    Purpose

    Sunscreen

  • USES

    Uses: Helps prevent sunburn. If used as
    directed with other sun protection measures
    (see directions), decreases the risk of skin
    cancer and early skin ageing caused by the sun.

  • WARNINGS

    Warnings: For external use only. Do not use
    on damaged or broken skin Avoid prolonged
    sun exposure. If it gets in your eyes, wash well
    with water. Keep out of reach of children.
    Stop use and ask a doctor if rashes occur.
    If product is swallowed, get medical help or
    contact a Poison Control Center right away.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

    DIRECTIONS

    • SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE.
    • Reapply after 80 minutes of swimming or sweating.
    • Reapply immediately after towel drying.
    • Reapply at least every 2 hours.
    • Children under 3 years of age: Ask a doctor.

    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 value of 15 or higher and other sun protection measures including:

    • Limit time in the sun, especially from 10.00AM - 2.00PM
    • Wear long-sleeved shirts, pants, hats, and sunglasses
  • INACTIVE INGREDIENTS

    Inactive Ingredients: Aluminum Hydroxide,
    Aqua, Butyloctyl Salicylate, C12-15 Alkyl
    Benzoate, Coco-Caprylate/Caprate, Dimethicone,
    Ethylhexyl Methoxycrylene, Ethylhexylglycerin,
    Hydroxyacetophenone, Simmondsia Chinensis
    (Jojoba) Seed, Dunaliella Salina Extract, Iron
    Oxides, Isododecane, Isostearic Acid, Lauryl
    PEG-8 Dimethicone, Magnesium Sulfate, Mica,
    Phenoxyethanol, Polyglyceryl-2 Tetraisostearate,
    Polyglyceryl-2 Tetraisostearate, Polyglyceryl-3
    Polyricinoleate, Propanediol, Sodium Hyaluronate,
    Stearic Acid, Hibiscus sabdariffa Flower Extract

  • OTHER INFORMATION

    Other Information: Protect this product
    from excess heat and direct sun. Store below
    30°C / 86°F.

  • USER SAFETY WARNINGS

    Directions: Shake well before use.
    Apply liberally and reapply every 80 minutes,
    especially after swimming or towel drying.
    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
    value of 15 or higher and other sun protection
    measures including: Limit lime in the sun,
    especially from 10 am-2 pm Wear longsleeved
    shirts, pants, hats, and sunglasses For
    Children under 6 months of age ask a doctor

  • Label

    21

  • INGREDIENTS AND APPEARANCE
    NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS ILLUMINATING 40ML WITH PINK ALGAE  SPF 50
    titanium oxide, zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62282-986
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.3 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    WATER (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-2 TETRAISOSTEARATE (UNII: KN8R167SEQ)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)  
    MICA (UNII: V8A1AW0880)  
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    ISODODECANE (UNII: A8289P68Y2)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    DUNALIELLA SALINA (UNII: F4O1DKI9A6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62282-986-0140 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/01/2024
    2NDC:62282-986-0250 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/01/2024
    3NDC:62282-986-0315 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/30/2023
    Labeler - Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho (929572014)