Label: SUPER SENSITIVE DIAPER RASH- zinc oxide cream

  • NDC Code(s): 52915-140-05, 52915-140-29
  • Packager: ORGANIC & SUSTAINABLE BEAUTY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 8, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc Oxide 12%

  • Purpose

    Skin Protectant

  • Uses

    Helps treat and prevent diaper rash

    • Protects chafed skin due to diaper rash
    • Helps seal out wetness
  • Warnings

    For external use only

    When using this product: keep out of eyes. Rinse with water to remove

    Stop use and ask a doctor if: condition worsens. If symptoms last more than 7 days or clear up and occur again within a few days

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

  • Directions

    Apply an even layer for everyday protection and when a rash is present

  • Other information

    Protect the product in this container from excessive heat and direct sunlight

    • Report serious adverse reactions to: 5933 Bowcroft St. Los Angeles, CA 90016
  • Inactive ingredients

    Glyceryl starch, caprylic/capric triglyceride, lanolin, glyceryl stearate, cetearyl alcohol, glyceryl caprylate, cocos nucifera (coconut) oil, euphorbia cerifera (candelilla) wax, stearyl glycyrrhetinate (licorice).

  • PRINCIPAL DISPLAY PANEL - 82 g Tube Label

    CALIF♥RNIA BABY®

    TRUSTED
    SINCE 1995

    therapeutic relief™

    SUPER SENSITIVE™
    DIAPER RASH
    OINTMENT
    SKIN PROTECTANT

    PRESERVATIVE FREE

    USDA Certified Biobased
    Product 100%

    TREATS, PREVENTS & PROTECTS
    NO ADDED FRAGRANCE

    BABIES + KIDS + ADULTS

    ALLERGY
    TESTED

    © 2019

    NET WT 82 g/2.9 oz.

    USDA
    CERTIFIED
    BIOBASED
    PRODUCT
    PRODUCT 100%

    PRINCIPAL DISPLAY PANEL - 82 g Tube Label
  • INGREDIENTS AND APPEARANCE
    SUPER SENSITIVE DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52915-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE120 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHYLIMIDAZOLIDINONE RICE STARCH (UNII: 43YT4X3R70)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    lanolin (UNII: 7EV65EAW6H)  
    glyceryl stearate SE (UNII: FCZ5MH785I)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    stearyl glycyrrhetinate (UNII: 3YYE6VJS0P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52915-140-2982 g in 1 TUBE; Type 0: Not a Combination Product08/31/2015
    2NDC:52915-140-0514 g in 1 TUBE; Type 0: Not a Combination Product08/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01608/31/2015
    Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)
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