JAFRA ROYAL MEN SAMPLE SET- avobenzone, homosalate 
Jafra International Cosmetics

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.

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Jafra Royal Men Royal Jelly Sample set

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen

Uses

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

Stop use and ask a doctor if rash occurs

Warnings

Do not use on damaged or broken skin

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

Directions

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

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.

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

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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)

Revised: 4/2019
Document Id: 860ae5f3-bf2d-73fa-e053-2991aa0a27d1
Set id: 860ae5f3-bf2c-73fa-e053-2991aa0a27d1
Version: 1
Effective Time: 20190408
 
Jafra International Cosmetics