JAFRA ROYAL JELLY REVITALIZE- avobenzone, homosalate, octisalate, octocrylene kit

Jafra Royal Jelly Revitalize by

Drug Labeling and Warnings

Jafra Royal Jelly Revitalize by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL, 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 7%...........................................................Sunscreen

PURPOSE

Uses

• helps prevent sunburn

• if used as directed with other sunprotection 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 of 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
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water
to remove.

DOSAGE & ADMINISTRATION

Directions

• apply liberally 15 minutes before sun exposure

• use a water resistant sunscreen if swimming or sweating

• reapply 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 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-sleeve shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Inactive ingredients
Acrylates/C10-30 Alkyl AcrylateCrosspolymer, Acrylates/Dimethicone Copolymer, Actinidia Chinensis(Kiwi) Fruit Water, Alcohol,Allantoin, Aluminum Starch Octenylsuccinate, Arachidy lAlcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Benzyl Alcohol, Bisabolol, Butylene Glycol, Butyrospermum Parkii(Shea) Butter, Chlorphenesin, Cocos Nucifera Fruit Extract, Cyclopentasiloxane, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin,Fragrance/Parfum, Glycerin,Glyceryl Stearate, Hydrogenated Lecithin, Lauroyl Lysine, Lecithin,Maltodextrin, Moringa Oleifera Leaf Extract, PEG-100 Stearate, Phenethyl Alcohol, Polygonum Aviculare Extract, Royal Jelly,Sodium Ascorbyl Phosphate,Sophora Flavescens Root Extract, Styrene/Acrylates Copolymer, Tetrapeptide-45,Water/Aqua

PRINCIPAL DISPLAY PANEL

Jafra Royal

Royal Jelly

Revitalize

1 Gentle Cleansing Milk
30 ml 1 FL OZ (US)
1 Longevity Crème
14 ml 0.47 FL OZ (US)
1 Spot Serum
7,5 ml .25 FL OZ (US)
1 Solar Protection Fluid Broad Spectrum SPF 50
14 ml 0.47 FL OZ (US)
Contains: 4 Sample
Total Content 65,5 ml 2.21 FL OZ (US)

INGREDIENTS AND APPEARANCE

JAFRA ROYAL JELLY REVITALIZE 
avobenzone, homosalate, octisalate, octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-500

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-500-01	1 in 1 PACKAGE; Type 0: Not a Combination Product	04/27/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	14 mL
Part 2	1 PACKAGE	7.5 mL
Part 3	1 TUBE	30 mL
Part 4	1 TUBE	14 mL

Part 1 of 4

SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Item Code (Source)	NDC: 68828-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
KIWI FRUIT OIL (UNII: 66086CWP3Q)
ALCOHOL (UNII: 3K9958V90M)
ALLANTOIN (UNII: 344S277G0Z)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ARGININE (UNII: 94ZLA3W45F)
DOCOSANOL (UNII: 9G1OE216XY)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SHEA BUTTER (UNII: K49155WL9Y)
CHLORPHENESIN (UNII: I670DAL4SZ)
COCONUT (UNII: 3RT3536DHY)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
LAUROYL LYSINE (UNII: 113171Q70B)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
ROYAL JELLY (UNII: L497I37F0C)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-501-01	14 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68828-501-02	7.5 mL in 1 PACKAGE; 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

Part 2 of 4

SPOT SERUM 
cleansing (cold creams, cleansing lotions, liquids, and pads)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	OCTYLDODECANOL (UNII: 461N1O614Y)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	KIWI FRUIT OIL (UNII: 66086CWP3Q)
INGR	SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
INGR	GARDEN CRESS SPROUT (UNII: PWQ18YNR62)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	ROYAL JELLY (UNII: L497I37F0C)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
INGR	SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
INGR	DMDM HYDANTOIN (UNII: BYR0546TOW)
INGR	IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
INGR	COCONUT (UNII: 3RT3536DHY)
INGR	MORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B)
INGR	EDETATE TRISODIUM (UNII: 420IP921MB)
INGR	ALCOHOL (UNII: 3K9958V90M)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	BENZYL SALICYLATE (UNII: WAO5MNK9TU)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
INGR	BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
INGR	LINALOOL, (+)- (UNII: F4VNO44C09)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		04/26/2018

Part 3 of 4

GENTLE CLEANSING MILK 
cleansing (cold creams, cleansing lotions, liquids, and pads)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
INGR	COCO GLUCOSIDE (UNII: ICS790225B)
INGR	ROYAL JELLY (UNII: L497I37F0C)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	GLYCOL STEARATE (UNII: 0324G66D0E)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	BENZOIC ACID (UNII: 8SKN0B0MIM)
INGR	DEHYDROACETIC ACID (UNII: 2KAG279R6R)
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	EDETATE SODIUM (UNII: MP1J8420LU)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
INGR	POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	BENZYL SALICYLATE (UNII: WAO5MNK9TU)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
INGR	BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
INGR	LINALOOL, (+)- (UNII: F4VNO44C09)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2		7.5 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Part 4 of 4

LONGEVITY CREME 
cleansing (cold creams, cleansing lotions, liquids, and pads)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
INGR	ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	PENTYLENE GLYCOL (UNII: 50C1307PZG)
INGR	DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
INGR	STEARYL STEARATE (UNII: 5WX2EGD0DK)
INGR	ROYAL JELLY (UNII: L497I37F0C)
INGR	HONEY (UNII: Y9H1V576FH)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
INGR	PALMITOYL GLYCINE (UNII: M6V3RIU5KI)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	SQUALENE (UNII: 7QWM220FJH)
INGR	ALFALFA (UNII: DJO934BRBD)
INGR	COCONUT OIL (UNII: Q9L0O73W7L)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	EDETATE TRISODIUM (UNII: 420IP921MB)
INGR	PEG-4 LAURATE (UNII: AYF4VM3N1Z)
INGR	IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	DMDM HYDANTOIN (UNII: BYR0546TOW)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	ASCORBYL PALMITATE (UNII: QN83US2B0N)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	BENZYL SALICYLATE (UNII: WAO5MNK9TU)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
INGR	BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
INGR	LINALOOL, (+)- (UNII: F4VNO44C09)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		14 mL in 1 TUBE; Type 0: Not a Combination Product
2		7.5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/27/2018

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V		814732061	manufacture(68828-500, 68828-501)