Label: JAFRA ROYAL MEN SAMPLE SET- avobenzone, homosalate kit

  • NDC Code(s): 68828-395-01, 68828-396-01
  • Packager: Jafra International Cosmetics
  • 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 April 8, 2019

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

  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Avobenzone 3% Sunscreen

    Homosalate 10% Sunscreen

    Octisalate 5% Sunscreen

    Octocrylene 10% Sunscreen

  • PURPOSE

    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
  • KEEP OUT OF REACH OF CHILDREN

    Keep out reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    Warnings

    Do not use on damaged or broken skin

    Whe using this product keep out of eyes. RInse with water to remove.

  • DOSAGE & ADMINISTRATION

    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: 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 15 or higher and other sun protection measures including:
    Limit time in the sun, especially from 10a.m. – 2p.m.
    Wear long-sleeve shirts, pants, hats, and sunglasses

  • INACTIVE INGREDIENT

    INGREDIENTS/INGREDIENTES: Water/Aqua, Glycerin, Cetearyl Alcohol, Ceteareth-20, Sodium Pca, Stearyl Stearate, Heptyl Undecylenate, C13-16 Isoparaffin, Dimethicone, Royal Jelly Powder, lecithin, Dipropylene Glycol, Royal Jelly, Tetrapeptide-45, Hydrogenated Lecithin, Sodium Hyaluronate, Hydroxyethyl Urea, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin,
    Hexylene Glycol, Hydrolyzed Myrtus Communis Leaf Extract, Butylene Glycol, Rosa Canina Fruit Extract,
    Palmaria Palmata (Red Seaweed) Extract, Triethanolamine, Myristyl Myristate, Sodium Acrylates Crosspolymer-2, Bis-Diglyceryl Polyacyladipate-2, Salix Alba (Willow) Bark Extract, Bisabolol, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Panthenol, Caffeine, Tocopheryl Acetate, Fragrance/Parfum, Butylphenyl Methylpropional (Lillial), Citral, Citronellol, Coumarin, Limonene, Linalool, Butyrospermum Parkii (Shea) Butter, Phenethyl Alcohol, Maltodextrin, Quercus Petraea Fruit Extract, Trisodium Edta.

  • PRINCIPAL DISPLAY PANEL

    Jafra Royal Men

    Contains 4 samples

    3-in-1 Face Moisturizer Broad Spectrum SPF 20

    7.5 ml 0.25 FL OZ

    Clean + Condition Face Wash

    7.5ml 1 FL OZ

    Post Shave Face Tonic

    25 ml 0.84 FL OZ

    Age Defense Face Hydrator

    7.5 ml 1 FL OZ

    back

    front

  • INGREDIENTS AND APPEARANCE
    JAFRA ROYAL MEN SAMPLE SET 
    avobenzone, homosalate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-395
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-395-011 in 1 KIT; Type 1: Convenience Kit of Co-Package04/09/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 JAR 7.5 mL  in 100 
    Part 21 JAR 7.5 mL  in 100 
    Part 31 JAR 25 mL  in 100 
    Part 41 JAR 7.5 mL  in 100 
    Part 1 of 4
    3-IN-1 FACE MOISTURIZER BROAD SPECTRUM SPF 20 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Item Code (Source)NDC:68828-396
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
    CAFFEINE (UNII: 3G6A5W338E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    TRIACETIN (UNII: XHX3C3X673)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COCOA (UNII: D9108TZ9KG)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    ARGININE (UNII: 94ZLA3W45F)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    CITRAL (UNII: T7EU0O9VPP)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    COUMARIN (UNII: A4VZ22K1WT)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    ALLANTOIN (UNII: 344S277G0Z)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-396-017.5 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/09/2019
    Part 2 of 4
    CLEAN AND CONDITION FACE WASH 
    face and neck (excluding shaving preparations) cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    INGRSODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRCOCO GLUCOSIDE (UNII: ICS790225B)  
    INGRCOUMARIN (UNII: A4VZ22K1WT)  
    INGRDEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    INGRBUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    INGRTRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    INGRCAFFEINE (UNII: 3G6A5W338E)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRSALIX ALBA BARK (UNII: 205MXS71H7)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    INGRROYAL JELLY (UNII: L497I37F0C)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRBENZOIC ACID (UNII: 8SKN0B0MIM)  
    INGRSODIUM METHYL OLEOYL TAURATE (UNII: 8PZ076134H)  
    INGRLAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
    INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
    INGRCITRAL (UNII: T7EU0O9VPP)  
    INGRHYDROXYCITRONELLOL (UNII: R0B4U2I48W)  
    INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    17.5 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic04/09/2019
    Part 3 of 4
    POST SHAVE FACE TONIC 
    preshave lotions (all types) liquid
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRHAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGRROYAL JELLY (UNII: L497I37F0C)  
    INGRSALICYLIC ACID (UNII: O414PZ4LPZ)  
    INGRCAFFEINE (UNII: 3G6A5W338E)  
    INGRLEVOMENOL (UNII: 24WE03BX2T)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRSALIX ALBA BARK (UNII: 205MXS71H7)  
    INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
    INGRTRIACETIN (UNII: XHX3C3X673)  
    INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    INGRTROLAMINE (UNII: 9O3K93S3TK)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRPPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRPOLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRALCOHOL (UNII: 3K9958V90M)  
    INGRTREHALOSE (UNII: B8WCK70T7I)  
    INGRPOLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    INGRUREA (UNII: 8W8T17847W)  
    INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
    INGRWATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    125 mL in 1 JAR; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic04/09/2019
    Part 4 of 4
    AGE DEFENSE FACE HYDRATOR 
    face and neck (excluding shaving preparations) jelly
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    INGRROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    INGRTROLAMINE (UNII: 9O3K93S3TK)  
    INGRBIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
    INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
    INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRDULSE (UNII: 7832HOY4ZQ)  
    INGRLEVOMENOL (UNII: 24WE03BX2T)  
    INGRCARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    INGRCAFFEINE (UNII: 3G6A5W338E)  
    INGRCITRAL (UNII: T7EU0O9VPP)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRROYAL JELLY (UNII: L497I37F0C)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRMYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRHYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRSALIX ALBA BARK (UNII: 205MXS71H7)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPOLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGRSTEARYL STEARATE (UNII: 5WX2EGD0DK)  
    INGRHEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    INGRC13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
    INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRBUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    INGR.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    INGRCOUMARIN (UNII: A4VZ22K1WT)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    INGREDETATE TRISODIUM (UNII: 420IP921MB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    17.5 mL in 1 JAR; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic04/09/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/09/2019
    Labeler - Jafra International Cosmetics (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-395, 68828-396)