Label: SUDDEN CHANGE DERMA RENEWAL COMPLEX- octinoxate, zinc oxide cream

  • 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 September 8, 2021

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

View All Sections
  • Drug Facts

  • Active Ingredient

    Octinoxate 6.00%

    Zinc oxide 2.00%

    Purpose

    Sunscreen

  • Uses:

    Hepls prevent sunburn

  • 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 prevent sunburn, not skin cancer or 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 remove.

    Stop use and ask a doctor

    if rash occurs.

    Keep out of the reach of children.

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

  • Directions

    • For sunsreen use: 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.
  • Other Information

    • Protect this product from excessive heat and direct sun.
  • Inactive Ingredients

    WATER (AQUA), BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, SIMMONDSIA, CHINENSIS (JOJOBA) SEED OIL, GLYCERIN, DIMETHICONE, CETEARYL OLIVATE, HYDROGENATED OLIVE OIL, UNSAPONIFIABLES, CETYL ALCOHOL, SORBITAN OLIVATE, ALOE BARBADENSIS LEAF EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, TOCOPHERYL ACETATE, TETRAHEXYLDECYL ASCORBATE, SODIUM HYALURONATE, C12-15 ALKYL BENZOATE, TRIBEHENIN, CERAMIDE NG, PEG-10 RAPESEED STEROL, PALMITOYL HEXAPEPTIDE-12, XANTHAN GUM, ALLANTOIN, TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, CAPRYLYL GLYCOL, POTASSIUM SORBATE, HEXYLENE GLYCOL, BISABOLOL, FRAGRANCE, CITRUS AURANTIUM (NEROLI) FLOWER OIL

  • Questions or Comments?

    Call 1-800-595-6230

    Report any issues associated with this product to the telephone number or address listed on this package.

  • Package Labeling:

    Label4

  • INGREDIENTS AND APPEARANCE
    SUDDEN CHANGE DERMA RENEWAL COMPLEX 
    octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    HYDROGENATED OLIVE OIL (UNII: 53839415GI)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
    PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALLANTOIN (UNII: 344S277G0Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61543-0003-01 in 1 BOX04/01/2018
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2018
    Labeler - CCA Industries Inc. (106771041)
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!