Label: OBAGI MEDICAL WAY TO GLOW KIT- homosalate, octisalate, and zinc oxide kit

  • NDC Code(s): 62032-140-05, 62032-690-02
  • Packager: Obagi Cosmeceuticals LLC
  • 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 March 15, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose

    Homosalate 10%

    		Sunscreen

    Octisalate 5%

    		Sunscreen

    Zinc Oxide 16.5%

    		Sunscreen

  • 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

    • 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
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • 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: Ask a doctor
  • Inactive Ingredients

    Water (Aqua), C15-19 Alkane, Octyldodecyl Neopentanoate, Polymethylsilsesquioxane, Sorbitan Olivate, Silica, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (candelilla) Wax, Beeswax, Dimethicone

  • SPL UNCLASSIFIED SECTION

    Distributed by Obagi Cosmeceuticals LLC,
    Long Beach, CA 90806

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    Way to
    Glow
    Defend, Hydrate & Protect

    OBAGI®
    MEDICAL Kit Carton

  • INGREDIENTS AND APPEARANCE
    OBAGI MEDICAL WAY TO GLOW KIT 
    homosalate, octisalate, and zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-690
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-690-021 in 1 CARTON03/20/2023
    11 in 1 BAG; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 28 g
    Part 21 BOTTLE, DROPPER 30 mL
    Part 31 BOTTLE, PUMP 48 g
    Part 1 of 3
    SUN SHIELD BROAD SPECTRUM SPF 50 MATTE  SUNSCREEN
    homosalate, octisalate, and zinc oxide lotion
    Product Information
    Item Code (Source)NDC:62032-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE165 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    C15-19 ALKANE (UNII: CI87N1IM01)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-140-0528 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02003/20/2023
    Part 2 of 3
    OBAGI MEDICAL PROFESSIONAL-C SERUM 15 
    face and neck (excluding shaving preparations) liquid
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRALCOHOL (UNII: 3K9958V90M)  
    INGRASCORBIC ACID (UNII: PQ6CK8PD0R)  
    INGROCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGREVERNIA PRUNASTRI (UNII: O3034Q5AHK)  
    INGRGRAPEFRUIT PEEL (UNII: 3582N05Q44)  
    INGRASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    INGRPSEUDEVERNIA FURFURACEA (UNII: 49ZMN09Q0K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic03/20/2023
    Part 3 of 3
    OBAGI MEDICAL OBAGI HYDRATE FACIAL MOISTURIZER 
    moisturizing lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRAVOCADO OIL (UNII: 6VNO72PFC1)  
    INGRCAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRLEVOMENOL (UNII: 24WE03BX2T)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRSACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    INGRLAURETH-12 (UNII: OAH19558U1)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRSOY STEROL (UNII: PL360EPO9J)  
    INGRSOYBEAN (UNII: L7HT8F1ZOD)  
    INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
    INGRDIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRALLANTOIN (UNII: 344S277G0Z)  
    INGRCARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRMANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRSODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    INGRTETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRTOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    148 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic03/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02003/20/2023
    Labeler - Obagi Cosmeceuticals LLC (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.S.COSMECEUTICAL USA, INC.017014734manufacture(62032-690)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208manufacture(62032-690)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(62032-690)
    Establishment
    NameAddressID/FEIBusiness Operations
    Identipak, Inc.942862350pack(62032-690)
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