Label: HILTON SPF 30 MINERAL SUNSCREEN- zinc oxide cream
ORIOR SPF 30 MINERAL SUNSCREEN- zinc oxide cream

  • NDC Code(s): 73563-335-02, 73563-335-08, 73563-638-02, 73563-638-05
  • Packager: Body One, LLC
  • 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 22, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Zinc Oxide 21.6%

  • Purpose

    Sunscreen

  • Uses

    *
    Helps prevent sunburn.
    *
    higher SPF five more sunburn protection
    *
    retains SPF after 40 minutes of activity in the water
    *
    If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    Skin Cancer/Skin Aging Alert

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer of early skin aging.

    For External Use Only

    Do not use on damaged or broken skin.

    When using this product keep out of eyes. Rinse with water to removed. Stop use and ask a doctor if rash of irritation develops and lasts.

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

  • Directions

    *
    Apply liberally and evenly 15 minutes before sun exposure.
    *
    Reapply after 40 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.

    Children under 6 months of age: Ask a doctor.

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Inactive ingredients

    Aqua/water, ButylOctyl Salicylate, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Disteardimmonium Hectorite, EthylHexylglycerin, EthylhexylMethoxycrylene, Fragrance, Glycerine, Isostearic Acid, Lecithin, Magnesium Sulfate, Phenoxyethanol, Polyglyceryl-3 Diisostearate, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid.

  • Questions or comments?

    1-833-263-9663

  • PRINCIPAL DISPLAY PANEL - 59 ml. Bottle Label

    Hilton
    WAIKOLOA VILLAGE®

    MINERAL
    SUNSCREEN

    SPF 30
    BROAD SPECTRUM

    2 fl. oz. (59 ml.)
    www.hiltonwaikoloavillage.com

    Principal Display Panel - 59 ml. Bottle Label
  • PRINCIPAL DISPLAY PANEL - 150 mL Bottle Label

    ORIOR

    MINERAL
    SUNSCREEN
    LOTION

    SPF 30
    BROAD SPECTRUM

    5.0 fl.oz. 150 mL

    Principal Display Panel - 150 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HILTON SPF 30 MINERAL SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73563-335
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE21.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GUAIETOLIN, (S)- (UNII: L7635M8189)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    C13-15 Alkane (UNII: 114P5I43UJ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    LINALYL ACETATE (UNII: 5K47SSQ51G)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    ETHYL LINALOOL (UNII: SF2JS9GF5T)  
    TETRAHYDROLINALOOL (UNII: UM4XS5M134)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73563-335-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2023
    2NDC:73563-335-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/01/2023
    ORIOR SPF 30 MINERAL SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73563-638
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE21.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GUAIETOLIN, (S)- (UNII: L7635M8189)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    C13-15 Alkane (UNII: 114P5I43UJ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    LINALYL ACETATE (UNII: 5K47SSQ51G)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    ETHYL LINALOOL (UNII: SF2JS9GF5T)  
    TETRAHYDROLINALOOL (UNII: UM4XS5M134)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73563-638-05150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2023
    2NDC:73563-638-0250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/01/2023
    Labeler - Body One, LLC (117376115)
    Registrant - Solo Laboratories Inc (078831987)
    Establishment
    NameAddressID/FEIBusiness Operations
    Solo Laboratories Inc078831987MANUFACTURE(73563-335, 73563-638) , LABEL(73563-335, 73563-638) , PACK(73563-335, 73563-638)
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