Label: STAY AGELESS TINTED MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide and zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 19, 2022

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

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS:

  • ACTIVE INGREDIENTS

    Titanium Dioxide 7.75%, Zinc Oxide 10.0%.

  • Purpose

    Sunscreen

  • USES

    Helps prevent sunburn.

  • 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.

  • DIRECTIONS

    Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *For 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:

    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses.
  • INACTIVE INGREDIENTS

    Water (Aqua), Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Glycerin, Dimethicone, Styrene/Acrylates Copolymer, Coco-Caprylate/Caprate, Aluminum Stearate, Carthamus Tinctorius Oleosomes, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice, Polygonum Aviculare Extract, Tocopheryl Acetate, Perilla Frutescens Extract, Vitis Vinifera Fruit Cell Extract, Lepidium Sativum Sprout Extract, Squalane, Cetearyl Alcohol, Isononyl Isononanoate, Coco-Glucoside, Pentylene Glycol, Behenyl Alcohol, Xanthan Gum, Triethoxycaprylylsilane, Arachidyl Glucoside, Simmondsia Chinensis (Jojoba) Seed Oil, Stearic Acid, Sucrose Stearate, Phenethyl Alcohol, Tetrahexyldecyl Ascorbate, Glyceryl Caprylate, Ethylene/Propylene/Styrene Copolymer, Sorbitan Oleate, Polyglyceryl-2 Caprate, Propanediol, Alumina, Arachidyl Alcohol, Iron Oxides (CI 77492, CI 77491, CI 77499).

  • OTHER INFORMATION

    Protect the product in this container from excessive heat and direct sun.

  • Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 1.75 fl oz (50ml)

    Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 1.75 fl oz (50ml)
    Stay Ageless
    Tinted Mineral Sunscreen
    Broad Spectrum SPF 30
    1.75 fl oz (50ml)

  • INGREDIENTS AND APPEARANCE
    STAY AGELESS TINTED MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82704-0650
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.75 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    JOJOBA OIL (UNII: 724GKU717M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE STEARATE (UNII: 274KW0O50M)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    POLYGLYCERYL-2 CAPRATE (UNII: JX7WXJ41DH)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GARDEN CRESS SPROUT (UNII: PWQ18YNR62)  
    SQUALANE (UNII: GW89575KF9)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82704-0650-250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/19/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/19/2022
    Labeler - sknvcare, llc (118590753)