JAFRA ROYAL REVITALIZE 4 TUBE SET- avobenzone, homosalate, octisalate, octocrylene kit

JAFRA ROYAL REVITALIZE 4 TUBE SET by

Drug Labeling and Warnings

JAFRA ROYAL REVITALIZE 4 TUBE SET by is a Otc medication manufactured, distributed, or labeled by Distribuidora Comercial Jafra, S.A. de C.V., Jafra Cosmetics international Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

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

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

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.
• children under 6 months of age: 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 your time in the sun, especially from 10 a.m. – 2 p.m.

        wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Actinidia Chinensis (Kiwi) Fruit Water, Alcohol, Allantoin,

Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, 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

Other information

• protect this product from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

Product label

INGREDIENTS AND APPEARANCE

JAFRA ROYAL REVITALIZE 4 TUBE SET 
avobenzone, homosalate, octisalate, octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-522

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-522-01	1 in 1 KIT; Type 0: Not a Combination Product	12/20/2024

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

Part 1 of 4

GENTLE CLEANSING MILK 
other hair preparations, rinse-off [hair preparations (non-coloring)]

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
INGR	COCO GLUCOSIDE (UNII: ICS790225B)
INGR	DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
INGR	STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
INGR	SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
INGR	GLYCOL STEARATE (UNII: 0324G66D0E)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	EDETATE SODIUM (UNII: MP1J8420LU)
INGR	BENZOIC ACID (UNII: 8SKN0B0MIM)
INGR	DEHYDROACETIC ACID (UNII: 2KAG279R6R)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
INGR	ROYAL JELLY (UNII: L497I37F0C)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
INGR	BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 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		12/20/2024

Part 2 of 4

SPOT SERUM 
other hair preparations, leave-on [hair preparations (non-coloring)]

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	OCTYLDODECANOL (UNII: 461N1O614Y)
INGR	BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
INGR	SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	ROYAL JELLY (UNII: L497I37F0C)
INGR	KIWI FRUIT OIL (UNII: 66086CWP3Q)
INGR	DMDM HYDANTOIN (UNII: BYR0546TOW)
INGR	COCONUT (UNII: 3RT3536DHY)
INGR	EDETATE TRISODIUM (UNII: 420IP921MB)
INGR	SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
INGR	MORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B)
INGR	ALCOHOL (UNII: 3K9958V90M)
INGR	SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	GARDEN CRESS SPROUT (UNII: PWQ18YNR62)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	BENZYL SALICYLATE (UNII: WAO5MNK9TU)
INGR	BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
INGR	HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		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		12/20/2024

Part 3 of 4

LONGEVITY CREME 
other hair preparations, leave-on [hair preparations (non-coloring)]

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
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	PENTAERYTHRITYL DISTEARATE (UNII: 697WOT8HNB)
INGR	ROYAL JELLY (UNII: L497I37F0C)
INGR	HONEY (UNII: Y9H1V576FH)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
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	COCONUT OIL (UNII: Q9L0O73W7L)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
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: D81QY6I88E)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	MEDICAGO SATIVA WHOLE (UNII: DJO934BRBD)
INGR	BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		14 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		12/20/2024

Part 4 of 4

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

Product Information
Item Code (Source)	NDC: 68828-523
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	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
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)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
LAUROYL LYSINE (UNII: 113171Q70B)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B)
PEG-100 MONOSTEARATE (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)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-523-01	14 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/20/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/20/2024

Labeler - Distribuidora Comercial Jafra, S.A. de C.V. (951612777)

Registrant - Jafra Cosmetics international Inc. (031183599)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture(68828-522, 68828-523)