Label: SUNBLOCZ BABY AND KIDS- zinc oxide cream

  • NDC Code(s): 52358-0003-1
  • Packager: Olen Cosmetics Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 1, 2023

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Zinc Oxide 24.5%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses

    • Helps 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

    Warnings

    For external use only

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply liberally and evenly 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 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
    • Children under 6 months: Ask a doctor
  • STORAGE AND HANDLING

    Other information

    • Protect the product in this container from excessive heat and direct sun
  • INACTIVE INGREDIENT

    Inactive ingredients

    Grape Seed Oil, Safflower Oil, Beeswax, Candelilla wax, Rice Bran Wax, Green Tea, Lavender Essential Oil, Rosemary Essential Oil.

  • QUESTIONS

    Questions or comments?

    www.olencosmetics.com or call toll free 1-877-494-4313

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Olen Cosmetics Corporation

    31 Woodstone Drive

    East St. Paul, Manitoba

    Canada, R2EOM5

    Made in Canada

  • PRINCIPAL DISPLAY PANEL

    100% NATURAL

    ZINC OXIDE SUNSCREEN CREAM

    Sunblocz Baby & Kids

    BROAD SPECTRUM SPF 50

    UVA & UVB

    Water Resistant (80 minutes)

    Dermatologist Recommended

    Clinically Tested

    Hypoallergenic

    4 FL OZ (118 mL)

    SunBlocz Baby

  • INGREDIENTS AND APPEARANCE
    SUNBLOCZ BABY AND KIDS 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52358-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION28.9 g  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    CANDELILLA WAX (UNII: WL0328HX19)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    RICE BRAN (UNII: R60QEP13IC)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52358-0003-1118 mL in 1 TUBE; Type 0: Not a Combination Product06/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/21/2016
    Labeler - Olen Cosmetics Corporation (250916611)
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!