Label: ALOE UP MEDICATED LIP ICE SUNSCREEN SPF 30- homosalate, meradimate, octinoxate, oxybenzone lipstick

  • NDC Code(s): 61477-215-14
  • Packager: Aloe Care International, 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 April 13, 2022

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  • ACTIVE INGREDIENTS:

    HOMOSALATE (6%)

    MERADIMATE (4%)

    OCTINOXATE (7.5%)

    OXYBENZONE (4.5%)

  • PURPOSE:

    SUNSCREEN

  • USES

    HELPS PREVENT SUNBURN.

  • DIRECTIONS:

    APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.

    USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.

    REAPPLY AT LEAST EVERY 2 HOURS.

    CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

  • 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.

  • 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 or early skin aging.
    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.

  • INACTIVE INGREDIENTS

    ALOE VERA OIL, CAMPHOR, CETYL ALCOHOL, MENTHOL, MINERAL OIL, OZOKERITE WAX, PETROLATUM, TITANIUM DIOXIDE, TOCOPHEROL

  • OTHER INFORMATION

    • Protect this product from excessive heat and direct sun

  • Questions or comments?

    Toll Free 800-950-2563 www.aloeup.com

  • PRINCIPAL DISPLAY PANEL

    Aloe Up White Line SPF 30 Medicated Lip Balm

  • INGREDIENTS AND APPEARANCE
    ALOE UP MEDICATED LIP ICE SUNSCREEN   SPF 30
    homosalate, meradimate, octinoxate, oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61477-215
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6 g  in 100 g
    MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE4 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MENTHOL (UNII: L7T10EIP3A)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61477-215-144.25 g in 1 TUBE; Type 0: Not a Combination Product02/24/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/24/2014
    Labeler - Aloe Care International, LLC (938242187)
    Registrant - Aloe Care International, LLC (938242187)
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