Label: RADICALLY REJUVENATING DAY CREAM- zinc oxide cream

  • NDC Code(s): 54136-153-44
  • Packager: Better Planet Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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

  • Active ingredients

    Zinc Oxide 15.50%

  • Purpose

    Sunscreen

  • Uses

    * Help prevent sunburn * if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • Warnings

    For external use only.

    Do not use on damaged or broken skin.

    When using the product * keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs.

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

    May stain some fabrics.

  • Directions

    * apply liberally 15 minutes before sun exposure

    * 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 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 a.m.-2 p.m.

    * wear long-sleeve shirts, pants, hats, and sunglasses

  • Other information

    * Protect this product from excessive heat and direct sun

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Aloe Barbadensis Leaf Juice, Coconut Alkanes, Glycerin, Squalane, Ceteary| Olivate, Ceteary| Alcohol, Sorbitan Olivate, Panthenol, Tocopherol, Niacinamide, Ascorbic Acid, Curcuma Longa (Tumeric) Root Extract, Ferulic Acid, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Glycine Soja (Soybean) Oil, Argania Spinosa Kernel Oil, Tanacetum Annuum (Blue Tansy) Flower Oil, Sodium PCA, Sodium Hyaluronate, Allantoin, Lecithin, Bisabolol, Pullulan, Xanthan Gum, Sclerotium Gum, Caprylyl Glycol, Coco-Caprylate/Caprate, Heptyl Undecylenate, Polyhydroxystearic Acid, Cetearyl Glucoside, Silica, Hexylene Glycol, Caprylhydroxamic Acid

  • Questions or comments?

    Call 1-877-902-2873

  • PRINCIPAL DISPLAY PANEL

    SPF Day Cream Box ArtworkSPF Day Cream Tube Label

  • INGREDIENTS AND APPEARANCE
    RADICALLY REJUVENATING DAY CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54136-153
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TANACETUM ANNUUM FLOWERING TOP OIL (UNII: E2Q02N1ZC7)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    FERULIC ACID (UNII: AVM951ZWST)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TURMERIC (UNII: 856YO1Z64F)  
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SQUALANE (UNII: GW89575KF9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54136-153-441 in 1 CARTON04/09/2020
    152 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/09/2020
    Labeler - Better Planet Brands LLC (960253719)