Label: ALGODEFENSE RIDES MULTI PROTECTRICE MULTI-PROTECTIVE WRINKLE CREAM SUNSCREEN BROAD SPECTRUM SPF20- avobenzone, octinoxate, octisalate, octocrylene 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 March 21, 2019

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  • Drug Facts

  • Active Ingredients

    Avobenzone 2.7%
    Octinoxate 6.7%
    Octisalate 4.5%
    Octocrylene 5%

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn.
    • if used as directed with other sun protection measures (see Directions), decreases the risk of sun cancer and early skin aging caused by the sun.
  • Warnings

    For external use only

    Do not use

    on damaged skin 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 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 at least every two hours
    • use a water resistant sunscreen if swimming or sweating
    • Sun protections measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly 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 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • Other information

    • protect this product from excessive  heat and direct sun
  • Inactive Ingredients

    Water, glycerin, isononyl isononanoate, butylene glycol cocoate, methylsilanol hydroxyproline aspartate, cetearyl alcohol, dimethicone, olive oil decyl esters, sea water, butyrospermum parkii (shea) butter, phenoxyethanol, isododecane, caprylic/capric triglyceride, potassium cetyl phosphate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, cetearyl glucoside, fragrance, chlorphenesin, caprylyl glycol, xanthan gum, squalene, sea salt, disodium edta, dimethicone crosspolymer-3, laminaria digitata extract, tocopherol, polysorbate 60, sorbitan isostearate, crithmum maritimum extract, hydrolyzed algin, chlorella vulgaris extract, sodium hydroxide, sucrose, salicylic acid, sodium carrageenan, bht, ceteth-10, laureth-4, potassium sorbate, helianthus annuus (sunflower) seed oil, saccharide isomerate, ethylhexylglycerin, linalool, limonene, benzyl salicylate, geraniol, citral.

  • Questions or comments?

    Call toll free 1-800-227-8051

  • Package Labeling:

    Inner Package 3Label

  • INGREDIENTS AND APPEARANCE
    ALGODEFENSE RIDES MULTI PROTECTRICE MULTI-PROTECTIVE WRINKLE CREAM SUNSCREEN BROAD SPECTRUM SPF20 
    avobenzone, octinoxate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66846-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE27 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE67 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISODODECANE (UNII: A8289P68Y2)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SQUALENE (UNII: 7QWM220FJH)  
    SEA SALT (UNII: 87GE52P74G)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SUCROSE (UNII: C151H8M554)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    CARRAGEENAN SODIUM (UNII: 7CY8BVL34N)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETETH-10 (UNII: LF9X1PN3XJ)  
    LAURETH-4 (UNII: 6HQ855798J)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    GERANIOL (UNII: L837108USY)  
    CITRAL (UNII: T7EU0O9VPP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66846-016-0150 mL in 1 TUBE; Type 0: Not a Combination Product03/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/15/2019
    Labeler - Codif International (396156010)