Label: STAY ALL DAY 10-IN-1 ILLUMINATING SKIN VEIL BROAD-SPECTRUM SPF 30 SUNSCREEN WATER-RESISTANT 80 MINUTES KITTEN- octinoxate, 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 April 11, 2022

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  • Drug Facts

  • Active Ingredients

    Octinoxate 5.0%

    Zinc Oxide 18.6%

    Purpose

    Sunscreen

  • 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.

    Stop use and ask a doctor

    if rash occurs.

    When using this product

    keep out of eyes. Rinse with water to remove.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure and as needed
    • reapply at least every 2 hours
    • reapply after 80 minutes of swimming or sweating
    • reapply after towel drying
    • children under 6 months: 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 of 15 or higher and other sun protection measures including:
    • limit time in the sun especially from 10am - 2pm
    • wear long-sleeved shirts, pants, hats, and sunglasses

  • Other Information

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

  • Inactive ingredients :

    WATER/AQUA/EAU, C12-15 ALKYL BENZOATE, HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE, DIMETHICONE CROSSPOLYMER,-
    CYCLOPENTASILOXANE, GLYCERIN, ISOPENTYLDIOL, PYRUS MALUS (APPLE) FRUIT EXTRACT, ISODODECANE, DIMETHICONE, MICA, TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, SODIUM CHLORIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PHYSALIS ANGULATA EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DISTEARDIMONIUM HECTORITE, POLYHYDROXYSTEARIC ACID, SILICA, PEG/PPG-18/18 DIMETHICONE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, PROPYLENE CARBONATE, PARFUM, PHYTIC ACID, SODIUM HYDROXIDE, ROSMA R INUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, PALMITOYL TRIPEPTIDE-37, DECARBOXY CARNOSINE HCL, TOCOPHEROL, BUTYLENE GLYCOL, LINALOOL, HEXYL CINNAMAL. (+/-) IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891). <ILN C121042.2>

  • Package Labeling:

    Outer Package03Inner Package03

  • INGREDIENTS AND APPEARANCE
    STAY ALL DAY 10-IN-1 ILLUMINATING SKIN VEIL BROAD-SPECTRUM SPF 30 SUNSCREEN WATER-RESISTANT 80 MINUTES KITTEN 
    octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76049-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION186 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    APPLE (UNII: B423VGH5S9)  
    ISODODECANE (UNII: A8289P68Y2)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MICA (UNII: V8A1AW0880)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHYSALIS ANGULATA WHOLE (UNII: W4TKW9D5GG)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ROSEMARY (UNII: IJ67X351P9)  
    DECARBOXY CARNOSINE HYDROCHLORIDE (UNII: 6X7K9I5QR7)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76049-202-301 in 1 CARTON06/01/2021
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2021
    Labeler - Stila Style, LLC (809192896)
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