Label: ROYAL AND ANCIENT SUNCREEN- zinc oxide, octinoxate, octisalate, and oxybenzone lotion

  • 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 January 14, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose  
    Octinoxate5.9%Sunscreen
    Octisalate3.8%Sunscreen
    Oxybenzone4.7%Sunscreen
    Zinc Oxide6.4%Sunscreen
  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer & 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 a rash occurs

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

  • Directions

    • apply liberally 15 minutes before sun exposure reapply:
      • after 80 minutes of swimming or sweating
      • immediatly after towel drying
      • 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 10am-2pm
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • Inactive Ingredients

    Purified DI Water, Octyl Stearate/Octyl Palmitate/Dioctyl Adipate, Propylene Glycol, Glyceryl Stearate & Peg 100, Cetearyl Alcohol & Ceteareth 20, Xanthan Gum, Imidazolidinyl Urea, Methyl Paraben, Propyl Paraben, Crodafos N3N, and Vitamin E.

  • Other Information

    • protect this product from excessive heat and direct sun
  • Comment/Questions?

    Call 1-888-860-7424

  • PRINCIPAL DISPLAY PANEL - 50 ML Bottle Label

    ROYAL & ANCIENT

    SUNSCREEN
    SPF 30+
    BROAD SPECTRUM

    80 MINUTE WATER RESISTANCE

    1.7 FL. OZ. (50ML) e

    PRINCIPAL DISPLAY PANEL - 50 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    ROYAL AND ANCIENT SUNCREEN 
    zinc oxide, octinoxate, octisalate, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide64 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate59 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate38 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone47 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Diethylhexyl Adipate (UNII: MBY1SL921L)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Ethylhexyl Stearate (UNII: EG3PA2K3K5)  
    Diethanolamine Oleth-3 Phosphate (UNII: Y67NX5905E)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    .Alpha.-Tocopherol (UNII: H4N855PNZ1)  
    Imidurea (UNII: M629807ATL)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59555-104-0350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/21/2015
    2NDC:59555-104-10946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/21/2015
    3NDC:59555-104-113785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/21/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/21/2015
    Labeler - R & R Lotion, Inc (062979000)
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