Label: AGE DEFENSE MINERAL MOISTURIZER SPF 30- titanium dioxide lotion

  • 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 June 1, 2020

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  • ACTIVE INGREDIENT

    Titanium Dioxide 4.2%

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • WARNINGS

    For external use only

    Do not use on damaged or broken skin

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

    Stop use and ask a doctor if rash occurs

    Stop use and ask a doctor if rash occurs

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

  • Directions

    • Apply generously 15 minutes before sun exposure
    • Children under 6 months of age: Ask a doctor
    • 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 value of 15 or higher and other sun protection measures including:
    1. limit time in the sun, especially from 10 a.m. - 2 p.m.
    2. Wear long-sleeved shirts, pants, hats, and sunglasses
    • Reapply at least every 2 hours
    • Use a water-resistant sunscreen if swimming or sweating
  • Other Information

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

    Water (Aqua), Glyverin, Dimethicone, Pentylene Glycol, Ethylhexyl Methoxycrylene, Polyester-8, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyclyceryl-3 Polydimethylciloxyethyl Dimethicone, Squalane, Alumina, Phenoxyethanol, Enteromorpha Compressa (Green Algae) Extract, Polysorbate 60, Eugenia Caryophyllus (Clove) Leaf Oil, Hydrogen Dimethicone, Pisum Sativum (Pea) Extract, Carthamus Tinctorius (Safflower) Seed Oil, Ethylhexylglycerin, Acacia Decurrens Extract, Butylene Glycol, Caesalpinia Spinosa (Tara Tree) Gum, Vitis Rotundifolia (muscadine Grape) Fruis Extract, Tagetes Erecta Flower Extract, Cananga Odorata Flower Oil, Citric Acid, Alteromonas Ferment Extract Magnesium Ascorbyl Phosphate (Vitamin C), Panthenol (Vitamin B5), Coriandrum Sativum (Coriander) Fruit Oil, Vitis Vinifera (Grape) Seed Extract, 1,2-Hexanediol, Beta-Glucan, Caprylyl Glycol, Superoxide Dismutase.

  • PRINCIPAL DISPLAY PANEL

    50 mL NDC: 59899-051-0150 mL NDC: 59899-051-01

  • INGREDIENTS AND APPEARANCE
    AGE DEFENSE MINERAL MOISTURIZER SPF 30 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59899-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE42 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALTEROMONAS MACLEODII (UNII: BPX036043D)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    PEA (UNII: W4X7H8GYFM)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CORIANDER OIL (UNII: 7626GC95E5)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ACACIA DECURRENS WHOLE (UNII: 8KZ75S2VSK)  
    WATER (UNII: 059QF0KO0R)  
    ULVA COMPRESSA (UNII: SXZ209FM33)  
    SQUALANE (UNII: GW89575KF9)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TAGETES ERECTA FLOWER (UNII: UH5X33P33E)  
    CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    MUSCADINE GRAPE (UNII: 072T3X480E)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    CLOVE LEAF OIL (UNII: VCA5491KVF)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59899-051-021 in 1 CARTON06/01/2020
    1NDC:59899-051-0150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/01/2020
    Labeler - Shaklee Corporation (020284076)
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