Label: DAYTIME DEFENSE SPF 30- zinc oxide cream

  • NDC Code(s): 66915-611-01, 66915-611-02, 66915-611-03
  • Packager: CoValence, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/12

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

  • ACTIVE INGREDIENT

    Active Ingredients:  Zinc Oxide 13.5%
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  • PURPOSE

    Purpose:  Sunscreen

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • INDICATIONS & USAGE

    Use: 

    • Helps prevent sunburn
    • For skin highly sensitive to sunburn
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  • WARNINGS

    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 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.
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  • DOSAGE & ADMINISTRATION

    Directions:

    • Apply liberally 15 minutes before sun exposure.
    • Use water resistant sunscreen if swimming or sweating.
    • Reapply 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 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.
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  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Aqua (Water). Caprylic/Capric Triglyceride, Glycerin, Ethyl Macadamiate, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glyceryl Stearate, Isodecyl Neopentanoate, Polyglyceryl-10 Pentastearate, Hydrolyzed Starch Phosphate, Cirtric Acid, Cetearyl Alcohol, Sodium Stearoyl Lactylate, Behenyl Alcohol, Phellodendrom Amurense (Cork Tree) Bark Extract, Glyceryl Isostearate, Hydroxypropyl Methylcellulose, Sodium Stearoyl Lactylate, Alcohol Denatured, Santalum Album (Sandalwood) Extract, Hordeum Distichon (Barley) Extract, Artemisia Vulgaris (Mugwort) Extract, Algae Extract, Malic Acid, Tocopherol, Hamamelis Virginiana (Witch Hazel) Water, Lonicera Caprifolium (Honeysuckle) Flower Extract, Sodium Chloride, Sodium Hydroxide

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel:66915 611 02 Label

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  • INGREDIENTS AND APPEARANCE
    DAYTIME DEFENSE SPF 30 
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66915-611
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE .135 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    MEDIUM-CHAIN TRIGLYCERIDES  
    ETHYL MACADAMIATE  
    ISODECYL NEOPENTANOATE  
    GLYCERIN  
    GLYCERYL MONOSTEARATE  
    BARLEY  
    LAVENDER OIL  
    SANDALWOOD  
    PHELLODENDRON AMURENSE BARK  
    ARTEMISIA VULGARIS ROOT  
    .ALPHA.-TOCOPHEROL, DL-  
    MALIC ACID, L-  
    LONICERA CAPRIFOLIUM FLOWER  
    LONICERA JAPONICA FLOWER  
    GLYCERYL ISOSTEARATE  
    SODIUM STEAROYL LACTYLATE  
    DOCOSANOL  
    CETOSTEARYL ALCOHOL  
    POLYHYDROXYSTEARIC ACID (2300 MW)  
    SODIUM CHLORIDE  
    HAMAMELIS VIRGINIANA TOP WATER  
    ALCOHOL  
    CITRIC ACID MONOHYDRATE  
    FYTIC ACID  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66915-611-01 200000 g in 1 DRUM
    2 NDC:66915-611-02 30 g in 1 BOTTLE, PLASTIC
    3 NDC:66915-611-03 120 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 04/26/2012
    Labeler - CoValence, Inc. (070653204)
    Registrant - CoValence, Inc. (070653204)
    Establishment
    Name Address ID/FEI Business Operations
    CoValence, Inc. 070653204 manufacture(66915-611)
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