Label: SAFEWAY SIGNATURE CARE NO BREAKOUT SUNSCREEN FACE SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 23, 2023

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  • Active ingredients

    Avobenzone 2.5%, Homosalate 6.0%, Octisalate 4.0%, Octocrylene 3.0%

  • 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 aging caused by the sun
  • Warnings

    For external use only

  • Do not use on

    • 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:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • children under 6 months of age: 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 sunglasses
  • Other Information

    • protect the product in this container from excessive heat and direct sun
    • may stain or damage some fabrics, materials or surfaces
  • Inactive ingredients

    water, tridecyl salicylate, silica, styrene acrylates copolymer, C12-15 alkyl benzoate, cetyl dimethicone, dimethicone, acrylates/dimethicone copolymer, phenoxyethanol, xanthan gum, steareth-100, steareth-2, adipic acid/diglycol crosspolymer, caprylyl glycol, sodium polyacrylate, glycerin, ethylhexylglycerin, ethylhexyl stearate, disodium EDTA, trideceth-6, bisabolol, mannan, propylene glycol, butylene glycol, capryloyl glycine, cedrus atlantica bark extract, hexylene glycol, sarcosine, portulaca oleracea extract, cinnamomum zeylancium bark extract, chlorphenesin.

  • Label

    SY13212A1

  • INGREDIENTS AND APPEARANCE
    SAFEWAY SIGNATURE CARE NO BREAKOUT SUNSCREEN FACE SPF 30 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-753
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE60 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE30 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    WATER (UNII: 059QF0KO0R)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PURSLANE (UNII: M6S840WXG5)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    KONJAC MANNAN (UNII: 36W3E5TAMG)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    STEARETH-100 (UNII: 4OH5W9UM87)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF)  
    STEARETH-2 (UNII: V56DFE46J5)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    SARCOSINE (UNII: Z711V88R5F)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETYL DIMETHICONE 45 (UNII: IK315POC44)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-753-0388 mL in 1 TUBE; Type 0: Not a Combination Product10/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02010/15/2019
    Labeler - Safeway, Inc. (009137209)
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