Label: MALIE ORGANICS REEF SAFE SUNSCREEN SPF-50- homosalate, octocrylene, octisalate, zinc oxide cream

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

Drug Label Information

Updated November 11, 2023

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

View All Sections
  • Drug Facts

  • Active-Ingredients

    Homosalate 10%

    Octocrylene 8%

    Octisalate 5%

    Zinc-Oxide 5%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
    • Retains SPF for 80 minutes of swimming or sweating 
    • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
  • Warnings

    not intended for ingestion. 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 develops and laste.

    Keep out of reach of children.

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

  • Directions

    • Apply liberally 15 minutes before sun exposure and as needed.
    • Children under 6 months of age: ask a doctor.
    • Reapply: After 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours.
    • Sun Protection Measures: 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: Limit time in the sun, especially from 10 am.m -2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.
  • Other Information

    • Protect the product in this container from excessive heat & direct sun.
    • This sustainable packaging is Earth-friendly & made in the USA using sugar cane derived resin, please Recycle this tube.
  • Inactive Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Bixa Orellana (Annatto) Extract, Bromelain (Pineapple), Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Carnauba Wax, Caprylyl/Capryl Glucoside, Carthamus Tinctorius (Safflower) Oil, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Extract, Glycerin, Glycyrrhiza Glabra (Licorice) Extract, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Hippophae Rhamnoides (Sea Buckthron) Oil, Lecithin, Parfum (Fragrance), Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract, Zemea (Corn) Propanediol.

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    MALIE ORGANICS REEF SAFE SUNSCREEN SPF-50 
    homosalate, octocrylene, octisalate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73731-083
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ANNATTO (UNII: 6PQP1V1B6O)  
    BROMELAINS (UNII: U182GP2CF3)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    TURMERIC (UNII: 856YO1Z64F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73731-083-05150 mL in 1 TUBE; Type 0: Not a Combination Product03/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/20/2020
    Labeler - Malie, Inc. (164892056)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!