Label: PRIME TIME DAILY PROTECTING PRIMER SPF 30- spf 30 prime time primer lotion

  • NDC Code(s): 51514-0364-1, 51514-0364-2
  • Packager: Autumn Harp Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 3, 2024

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

View All Sections
  • Drug Facts

  • Active Ingredients

    Titanium Dioxide 3.1%

    Zinc Oxide 10.49%

  • Purpose

  • INDICATIONS & USAGE

    Sunscreen

    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.

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

  • Directions

    • For sunscreen use:
    • 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 value of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 am - 2 pm
    • wear long sleeve shirts, pants, hats and sunglasses
    • children under 6 months of age: Ask a doctor
  • Other Information

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

  • Inactive Ingredients

    Water, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Undecane, Polyglyceryl-6 Polyricinoleate, Tapioca Starch, Glycerin, Tridecane, Magnesium Sulfate, Polyglyceryl-2 Isostearate, Tocopherol, Hydrogenated Vegetable Oil, Phenoxyethanol, Glyceryl Isostearate, Disteardimonium Hectorite, Polyhydroxystearic Acid, Propanediol, Bisabolol, Stearic Acid, Iron Oxide (CI 77492), Alumina, 1,2-Hexanediol, Isononyl Isononanoate, Camellia Japonica Seed Oil, Theobroma Cacao (Cocoa) Extract, Butylene Glycol, Isopropyl Myristate, Isostearic Acid, Iron Oxides (CI 77491), Caprylhydroxamic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Triethoxycaprylylsilane, Biosaccharide gum-4, Isopropyl Titanium Triisostearate, Stearalkonium Hectorite, Propylene Carbonate.

  • Questions?

    Call toll free 1-888-795-4747

  • Principle Display Panel

    Image Content

    TubeCarton

  • INGREDIENTS AND APPEARANCE
    PRIME TIME DAILY PROTECTING PRIMER SPF 30 
    spf 30 prime time primer lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0364
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10.49 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    UNDECANE (UNII: JV0QT00NUE)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    TRIDECANE (UNII: A3LZF0L939)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0364-21 in 1 CARTON01/02/2023
    1NDC:51514-0364-130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/02/2023
    Labeler - Autumn Harp Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp Inc.064187883manufacture(51514-0364)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!