FACIAL SUNSCREEN WITH ZINC SPF 50 DAYLOGIC (OCTINOXATE 7.50% OCTISALATE 5.00% OXYBENZONE 6.00% ZINC OXIDE 7.00%) CREAM [RITE AID]

FACIAL SUNSCREEN WITH ZINC SPF 50 DAYLOGIC (OCTINOXATE 7.50% OCTISALATE 5.00% OXYBENZONE 6.00% ZINC OXIDE 7.00%) CREAM [RITE AID]
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NDC 11822-1214-1
Set ID 8fb6968e-c70a-4f6d-8558-7882d48c511e
Category HUMAN OTC DRUG LABEL
Packager Rite Aid
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients                                                                     Purpose
    Octinoxate 7.5%.......................................................................Sunscreen
    Octisalate 5.0%........................................................................Sunscreen
    Oxybenzone 6.0%...................................................................Sunscreen
    Zinc Oxide 7.0%.......................................................................Sunscreen

  • PURPOSE

  • INDICATIONS & USAGE

    Uses • helps prevent sunburn

  • 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

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

  • DOSAGE & ADMINISTRATION

    Directions
    • apply liberally 15 minutes before sun exposure
    • reapply: • after 80 minutes of swimming or sweating
    • immediately after towel drying • 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

  • OTHER SAFETY INFORMATION

    Other information
    • protect this product from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Barbadensis Leaf Extract,
    Beeswax, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone,
    Cyclopentasiloxane, Cyclohexasiloxane, Diisopropyl Adipate, DMDM
    Hydantoin, Ethylhexyl Palmitate, Ethylhexyl Stearate, Glycerin, Hydrated
    Silica, Hydrogenated Castor Oil, Polyethylene, Sodium Chloride,
    Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate,
    Triethoxycaprylylsilane, Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FACIAL SUNSCREEN WITH ZINC SPF 50  DAYLOGIC
    octinoxate 7.50% octisalate 5.00% oxybenzone 6.00% zinc oxide 7.00% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1214
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone6 g  in 100 g
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Diisopropyl Adipate (UNII: P7E6YFV72X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Ethylhexyl Stearate (UNII: EG3PA2K3K5)  
    Glycerin (UNII: PDC6A3C0OX)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Hydrogenated Castor Oil (UNII: ZF94AP8MEY)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-1214-128.3 g in 1 JAR; Type 0: Not a Combination Product03/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/17/2017
    Labeler - Rite Aid (014578892)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(11822-1214) , label(11822-1214)

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