Label: SIMPLI DAY ALL IN ONE SMARTCREAM SPF 42- zinc oxide, octisalate, octocrylene, ensulizole 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.

  • Drug Facts

  • Active Ingredients

    Zinc Oxide 5%

    Octisalate 5%

    Octocrylene 5%

    Ensulizole 4%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • 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

    • 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 doctor

    • if rash or irritation occurs

    Keep out of each of children.

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

  • Directions

    • Apply liberally each morning 15 minutes before sun exposure.
    • During sun exposure, reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying 
    • at least every 2 hours
    • 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: Sun Protection Measures:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • Children under 6 months: ask a doctor
  • Other information

    • Protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Bakuchiol, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Ceramide NG, Cetearyl Alcohol, Citrullus Lanatus (Watermelon) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Ethylhexyl Palmitate, Ethylhexylglycerin, Ferulic Acid, I-Glutathione, Glycerin, Glyceryl Stearate, Hyaluronic Acid, Hydroxypropyl Cyclodextrin, Lamanaria Digitata (Sea Kelp) Extract, Lecithin, Niacinamide, Palmitoyl Tripeptide-38, Panthenol (Vitamin B5), Phenoxyethanol, Plankton Extract, Polyhydroxystearic Acid, Polypodium Leucotomos Extract, Polysorbate-20, Stearic Acid, Tocopherol (Vitamin E), Tridecyl Salicylate, Zemea (Corn) Propanediol

  • Questions or comments?

    Visit www.simpliskinmd.com

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SIMPLI DAY ALL IN ONE SMARTCREAM SPF 42 
    zinc oxide, octisalate, octocrylene, ensulizole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82733-294
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION50 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BAKUCHIOL (UNII: OT12HJU3AR)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATERMELON (UNII: 231473QB6R)  
    CUCUMBER (UNII: YY7C30VXJT)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERULIC ACID (UNII: AVM951ZWST)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82733-294-001 in 1 BOX05/20/2022
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/20/2022
    Labeler - SIMPLI SKIN MD LLC (113704769)