Label: SKINCEUTICALS CLEAR DAILY SOOTHING UV DEFENSE DAILY SUNSCREEN BROAD SPECTRUM SPF 50- homosalate, octisalate, octocrylene and zinc oxide lotion

  • NDC Code(s): 49967-992-01, 49967-992-02
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 14, 2024

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  • Active ingredients

    Homosalate 8%

    Octisalate 5%

    Octocrylene 5%

    Zinc oxide 7%

  • 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

  • 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ● apply liberally 15 minutes before sun exposure

    ● reapply at least every 2 hours

    ● use a water resistant sunscreen if swimming or sweating

    ● 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 sunglasses

    ● children under 6 months of age: Ask a doctor

  • Other information

    protect the product in this container from excessive heat and direct sun

  • Inactive ingredients

    water, glycerin, coco-caprylate/caprate, propanediol, butyloctyl salicylate, steareth-20, c12-22 alkyl acrylate/hydroxyethylacrylate copolymer, ethylhexyl methoxycrylene, oryza sativa (rice) bran wax, butylene glycol, steareth-2, bisabolol, hydroxyacetophenone, polyhydroxystearic acid, diethylhexyl syringylidenemalonate, chlorphenesin, caprylyl glycol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, citric acid, xanthan gum, triethoxycaprylylsilane, trisodium ethylenediamine disuccinate, caprylic/capric triglyceride, sorbitan isostearate, polysorbate 60, palmitoyl tripeptide-8, dextran

  • Questions or comments?

    Call 1-800-811-1660

    Monday - Friday (9 a.m. - 5 p.m. CST)

  • PRINCIPAL DISPLAY PANEL

    image of a cartonimage of a carton

    image of a carton
  • INGREDIENTS AND APPEARANCE
    SKINCEUTICALS CLEAR DAILY SOOTHING UV DEFENSE DAILY SUNSCREEN BROAD SPECTRUM SPF 50 
    homosalate, octisalate, octocrylene and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-992
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    RICE BRAN (UNII: R60QEP13IC)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    STEARETH-2 (UNII: V56DFE46J5)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PALMITOYL TRIPEPTIDE-8 (UNII: 55HZC7YQA7)  
    DEXTRAN 40 (UNII: K3R6ZDH4DU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-992-011 in 1 CARTON05/01/2024
    130 mL in 1 JAR; Type 0: Not a Combination Product
    2NDC:49967-992-024 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2024
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Beauty Manufacturing Solutions Corp.783200723manufacture(49967-992)
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