Label: NATURAL SPF 28- zinc oxide 11.6%, titanium dioxide 0.67% cream

  • NDC Code(s): 66915-604-02, 66915-604-07, 66915-604-08, 66915-604-12, view more
    66915-604-14, 66915-604-16, 66915-604-17, 66915-604-20, 66915-604-21, 66915-604-22, 66915-604-23, 66915-604-24, 66915-604-25, 66915-604-30
  • Packager: CoValence, Inc.
  • 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 December 2, 2013

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  • Active Ingredient(s):

    11.6% Zinc Oxide, 0.67% Titanium Dioxide

  • Purpose:

    Sunscreen

  • Warnings: (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.
  • 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:

    • 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 a rash occurs.
  • Directions:

    • Apply liberally 15 minutes before sun exposure.
    • Use a 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.
    • Children under 6 months:  Ask a doctor.
  • Inactive Ingredients:

    Alcohol, Allantoin, Aloe Barbadensis Leaf Juice Powder, Alumina, Aqua (Water), Caprylic/Capric Triglyceride, Ceteryl Alcohol, Cetearyl Glucoside, Citric Acid, Coco-Caprylate/Caprate, Dicaprylyl Ether, Fructooligosaccharides (D-Beta), Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Glyceryl Isostearate, Hamamelis Virginiana (Witch Hazel) Water, Isononyl Isononanoate, Magnesium Aluminum Silicate, Polyhydroxystearic Acid, Polyglyceryl-6 Polyricinoleate, Polysorbate 60, Potassium Sorbate, Simethicone, Sodium Benzoate, Squalane, Tocopheryl Acetate (D-alpha), Trisodium Ethylenediamine, Xanthan Gum

  • Other Information:

    Protect this product from excessive heat and direct sun.

  • PDP

    image description

  • INGREDIENTS AND APPEARANCE
    NATURAL SPF 28 
    zinc oxide 11.6%, titanium dioxide 0.67% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66915-604
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION.116 g  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE.0067 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 1 g  in 1 g
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 1 g  in 1 g
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 1 g  in 1 g
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) 1 g  in 1 g
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) 1 g  in 1 g
    POLYSORBATE 60 (UNII: CAL22UVI4M) 1 g  in 1 g
    GLYCERIN (UNII: PDC6A3C0OX) 1 g  in 1 g
    SQUALANE (UNII: GW89575KF9) 1 g  in 1 g
    POLYGLYCERYL-6 DIOLEATE (UNII: 062SZD3F3X) 1 g  in 1 g
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) 1 g  in 1 g
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) 1 g  in 1 g
    XANTHAN GUM (UNII: TTV12P4NEE) 1 g  in 1 g
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) 1 g  in 1 g
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 1 g  in 1 g
    ALUMINUM OXIDE (UNII: LMI26O6933) 1 g  in 1 g
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 1 g  in 1 g
    SOYBEAN OIL (UNII: 241ATL177A) 1 g  in 1 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 1 g  in 1 g
    DIMETHICONE (UNII: 92RU3N3Y1O) 1 g  in 1 g
    ALLANTOIN (UNII: 344S277G0Z) 1 g  in 1 g
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 1 g  in 1 g
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) 1 g  in 1 g
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 1 g  in 1 g
    POPULUS TREMULOIDES BARK (UNII: 5543O0CEID) 1 g  in 1 g
    DICAPRYLYL ETHER (UNII: 77JZM5516Z) 1 g  in 1 g
    1,2-HEXANEDIOL (UNII: TR046Y3K1G) 1 g  in 1 g
    CAPRYLYL GLYCOL (UNII: 00YIU5438U) 1 g  in 1 g
    GLUCONOLACTONE (UNII: WQ29KQ9POT) 1 g  in 1 g
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U) 1 g  in 1 g
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) 1 g  in 1 g
    TROPOLONE (UNII: 7L6DL16P1T) 1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66915-604-02200000 g in 1 DRUM
    2NDC:66915-604-241 in 1 PACKAGE
    2NDC:66915-604-07100 g in 1 BOTTLE
    3NDC:66915-604-221 in 1 PACKAGE
    3NDC:66915-604-0870 g in 1 TUBE
    4NDC:66915-604-251 in 1 PACKAGE
    4NDC:66915-604-12120 g in 1 TUBE
    5NDC:66915-604-1430 g in 1 BOTTLE
    6NDC:66915-604-1665 g in 1 JAR
    7NDC:66915-604-17135 g in 1 JAR
    8NDC:66915-604-231 in 1 PACKAGE
    8NDC:66915-604-2070 g in 1 TUBE
    9NDC:66915-604-2130 g in 1 BOTTLE
    10NDC:66915-604-3030 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/02/2013
    Labeler - CoValence, Inc. (070653204)
    Establishment
    NameAddressID/FEIBusiness Operations
    CoValence, Inc070653204manufacture(66915-604)
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