JAFRA ROYAL MEN SAMPLE SET- avobenzone, homosalate kit

Jafra Royal Men Sample Set by

Drug Labeling and Warnings

Jafra Royal Men Sample Set by is a Otc medication manufactured, distributed, or labeled by Jafra International Cosmetics, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

JAFRA ROYAL MEN SAMPLE SET 
avobenzone, homosalate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-395

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-395-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	04/09/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 JAR	7.5 mL  in 100
Part 2	1 JAR	7.5 mL  in 100
Part 3	1 JAR	25 mL  in 100
Part 4	1 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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-396-01	7.5 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/09/2019

Part 2 of 4

CLEAN AND CONDITION FACE WASH 
face and neck (excluding shaving preparations) cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	COCO GLUCOSIDE (UNII: ICS790225B)
INGR	COUMARIN (UNII: A4VZ22K1WT)
INGR	DEHYDROACETIC ACID (UNII: 2KAG279R6R)
INGR	BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
INGR	CAFFEINE (UNII: 3G6A5W338E)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	SALIX ALBA BARK (UNII: 205MXS71H7)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	ROYAL JELLY (UNII: L497I37F0C)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	BENZOIC ACID (UNII: 8SKN0B0MIM)
INGR	SODIUM METHYL OLEOYL TAURATE (UNII: 8PZ076134H)
INGR	LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
INGR	WATER (UNII: 059QF0KO0R)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	CITRAL (UNII: T7EU0O9VPP)
INGR	HYDROXYCITRONELLOL (UNII: R0B4U2I48W)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.5 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		04/09/2019

Part 3 of 4

POST SHAVE FACE TONIC 
preshave lotions (all types) liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	ROYAL JELLY (UNII: L497I37F0C)
INGR	SALICYLIC ACID (UNII: O414PZ4LPZ)
INGR	CAFFEINE (UNII: 3G6A5W338E)
INGR	LEVOMENOL (UNII: 24WE03BX2T)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	SALIX ALBA BARK (UNII: 205MXS71H7)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	TRIACETIN (UNII: XHX3C3X673)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	ALCOHOL (UNII: 3K9958V90M)
INGR	TREHALOSE (UNII: B8WCK70T7I)
INGR	POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
INGR	UREA (UNII: 8W8T17847W)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		25 mL in 1 JAR; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		04/09/2019

Part 4 of 4

AGE DEFENSE FACE HYDRATOR 
face and neck (excluding shaving preparations) jelly

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	DULSE (UNII: 7832HOY4ZQ)
INGR	LEVOMENOL (UNII: 24WE03BX2T)
INGR	CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
INGR	CAFFEINE (UNII: 3G6A5W338E)
INGR	CITRAL (UNII: T7EU0O9VPP)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	ROYAL JELLY (UNII: L497I37F0C)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
INGR	WATER (UNII: 059QF0KO0R)
INGR	HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	SALIX ALBA BARK (UNII: 205MXS71H7)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	STEARYL STEARATE (UNII: 5WX2EGD0DK)
INGR	HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
INGR	C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
INGR	.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
INGR	COUMARIN (UNII: A4VZ22K1WT)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	EDETATE TRISODIUM (UNII: 420IP921MB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.5 mL in 1 JAR; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		04/09/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/09/2019

Labeler - Jafra International Cosmetics (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-395, 68828-396)