Label: NAKED SUNDAYS BEACH DAY ALL OVER WATER MIST SPF 45- broad spectrum spf45 liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2024

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  • ACTIVE INGREDIENTS

    Active Ingredients:

    Avobenzone 1.5%

    Octocrylene 5%

    Phenylbenzimidazole Sulfonic Acid 3%

    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

    Keep out of eyes, Rinse with water to remove

    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

    Purified water, Sorbitol. Pentylene glycol , Hydroxyapatite, PEG/PPG Dimethicone, Potassium Chloride, Phenoxyethanol, Citrullus lantus , Sodium Hydroxide, Hydroxyacetophenone, Microcrystalline Cellulose, Cellulose gum, Silica, Ethylhexylglycerin, PVP, Fragrance ( Natural) , Aloe Barbadensis Leaf Juice, Sodium Benzoate

  • OTHER INFORMATION

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

  • USER SAFETY WARNINGS

    Directions: Avoid Eye Area, Shake well before use.

    Use as top up sunscreen only. Hold 8-10" away from your body and spray liberally & evenly until skin feels moist 15 minutes before sun exposure. Do not spray directly on to face. Make sure no spots are missed by spraying onto hands and applying to face. DO not apply in windy conditions.

    Use in well-ventilated area. Avoid inhalation. Use a water resistant sunscreen if swimming or sweating. Reapply immediately after towel drying. Reapply at least every 2 hours.

    Children under 6 months of age ask a doctor

  • PURPOSE

    Sunscreen

  • ASK DOCTOR

    If rashes occur

  • OTHER SAFETY INFORMATION

    Sun Protection measure

    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 measure including: Limit time in the sun,especially from 10:00 AM to 02:00 PM. Wea long sleeved shirts pants hats and sunglasses

  • Label

    1

  • INGREDIENTS AND APPEARANCE
    NAKED SUNDAYS BEACH DAY ALL OVER WATER MIST  SPF 45
    broad spectrum spf45 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81104-251
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE3 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    PEG-9 DIMETHICONE (UNII: 9OZ27X065D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    CITRULLUS LANATUS WHOLE (UNII: 3J5I6254YO)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    POVIDONE (UNII: FZ989GH94E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81104-251-0170 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/18/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/18/2024
    Labeler - NAKED SUNDAYS PTY LTD (746918845)
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