Label: PRO-TECT SUNSCREEN FOR PROFESSIONALS- meradimate, octinoxate, octisalate, 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 December 29, 2020

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  • Active ingredients

    Meradimate 5.0%

    Octinoxate 7.5%

    Octisalate 5.0%

    Oxybenzone 5.0%

  • Purpose

    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.
    Stop use and ask a doctor if rash occurs.
    When using this product keep out of eyes.
    Rinse with water to remove.
    Keep out of reach of children. If 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

    •immediately after towel drying
    •at least every 2 hours
    •children under 6 months: Ask a doctor
    • 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
    a.m.–2 p.m.
    •wear long-sleeved shirts, pants, hats, and
    sun-glasses

  • Other Information

    • Daily usage of Pro-Tect® SPF 30+ may help reduce the chance of premature aging of the skin due to overexposure to the sun. • This product provides more than 30 times your natural protection against sunburn. • Very Water Resistant UVA & UVB Broad-Spectrum Protection. • This product may stain light colored fabrics if washed with bleach. Wash clothing without bleach to remove safely.

  • Inactive Ingredients

    Aloe Vera Leaf, Benzyl Alcohol, C18-36 Acid Glycol Ester, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Cetyl Alcohol, Cetyl Dimethicone 45, Diazolidinyl Urea, Diethanolamine Cetyl Phosphate, dl-Alpha Tocopheryl Acetate, Eicosyl Povidone, Iodopropynyl Butylcarbamate, Lanolin, Mineral Oil, Stearic Acid, Talc, Trolamine, Water.

  • Questions or Comments

    1-800-922-2883

  • Package label

    NDC# 61619-866-08

    86608_8oz_V_0005.1_06172020_Master_Test

  • INGREDIENTS AND APPEARANCE
    PRO-TECT SUNSCREEN FOR PROFESSIONALS 
    meradimate, octinoxate, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61619-866
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE50 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LANOLIN (UNII: 7EV65EAW6H)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TALC (UNII: 7SEV7J4R1U)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL DIMETHICONE 45 (UNII: IK315POC44)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61619-866-32946.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2016
    2NDC:61619-866-0129.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2016
    3NDC:61619-866-0259.1 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2016
    4NDC:61619-866-04118.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2016
    5NDC:61619-866-08236.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/08/2016
    Labeler - A-Cute Derm, Incorporated (809845803)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(61619-866)
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