Label: BABO SOOTHING DIAPER CREAM- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 26, 2020

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

  • Babo Botanicals Soothing Diaper Cream (79265-9606-3)

    This is a diaper rash cream manufactured according to the Final Monograph for Skin Protectants with 25% Zinc Oxide.

  • Active Ingredient(s)

    Zinc Oxide 25% Purpose: Skin Protectant

  • Purpose

    Skin Protectant

  • Use

    Helps treat and prevent diaper rash • Protects chafed skin and minor irritation associated with diaper rash • Helps seal out wetness

  • Warnings

    For external use only.

  • WHEN USING

    When using this product avoid contact with eyes

  • STOP USE

    Stop use and ask a doctor if conditions worsens • symptoms last more than seven days • symptoms clear up and occur again within a few days

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply cream liberally and as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • Other information

    Protect this product from excessive heat and direct sun. You may report an adverse reaction to to the phone number or address provided below.

  • Inactive ingredients

    AVENA SATIVA (OAT) KERNEL EXTRACT, BUTYROSPERMUM PARKII (SHEA) BUTTER, CALENDULA OFFICINALIS FLOWER EXTRACT*, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, COCOS NUCIFERA (COCONUT) OIL, EUPHORBIA CERIFERA (CANDELILLA) WAX, FRAGRANCE (NATURAL), GLYCERIN*, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HYDROGENATED VEGETABLE OIL, LECITHIN, NASTURTIUM OFFICINALE (WATERCRESS) FLOWER/LEAF EXTRACT*, ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT, SPIRAEA ULMARIA (MEADOWSWEET) FLOWER EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER. *Certified Organic Ingredients

  • Package Label - Principal Display Panel

    3 oz. 85 g NDC: 79265-9606-3

    79265-9606 Outer Packaging

  • INGREDIENTS AND APPEARANCE
    BABO SOOTHING DIAPER CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79265-9606
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.000125 g  in 100 g
    ROSEMARY (UNII: IJ67X351P9) 0.25 g  in 100 g
    ISOEUGENOL (UNII: 5M0MWY797U) 0.000125 g  in 100 g
    CORN OIL (UNII: 8470G57WFM) 10 g  in 100 g
    NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G) 0.001 g  in 100 g
    CANANGA OIL (UNII: 8YOY78GNNX) 0.000125 g  in 100 g
    GERANIOL (UNII: L837108USY) 0.000125 g  in 100 g
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) 0.25 g  in 100 g
    CITRAL (UNII: T7EU0O9VPP) 0.000125 g  in 100 g
    OAT (UNII: Z6J799EAJK) 0.001 g  in 100 g
    SHEA BUTTER (UNII: K49155WL9Y) 5 g  in 100 g
    COCONUT OIL (UNII: Q9L0O73W7L) 10 g  in 100 g
    CANDELILLA WAX (UNII: WL0328HX19) 5 g  in 100 g
    SUNFLOWER OIL (UNII: 3W1JG795YI) 43.743 g  in 100 g
    COCOA BUTTER (UNII: 512OYT1CRR) 0.75 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 0.001 g  in 100 g
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 0.001 g  in 100 g
    FARNESOL (UNII: EB41QIU6JL) 0.000125 g  in 100 g
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) 0.001 g  in 100 g
    CHAMOMILE (UNII: FGL3685T2X) 0.001 g  in 100 g
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.000125 g  in 100 g
    EUGENOL (UNII: 3T8H1794QW) 0.000125 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79265-9606-385 g in 1 TUBE; Type 0: Not a Combination Product08/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/26/2020
    Labeler - Babo Botanicals, Inc. (058258734)
    Registrant - Royal Labs Natural Cosmetics, Inc. (197478480)
    Establishment
    NameAddressID/FEIBusiness Operations
    Royal Labs Natural Cosmetics, Inc.197478480manufacture(79265-9606)