JAFRA ROYAL LUNA BRIGHT KIT- avobenzone, homosalate, octisalate, octocrylene kit

Jafra Royal Luna Bright Kit by

Drug Labeling and Warnings

Jafra Royal Luna Bright Kit by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL INC, 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

Oxybenzone 7% 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 of reach of children. If product is 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 skin aging. to decrease

this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun 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 Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Allantoin, Aluminum Starch octenylsuccinate, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Arginine, Benzyl Alcohol, Bisabolol, Butyrospermum Parkii (Shea) Butter, Butylene Glycol, Chlorphenesin, Cyclopentasiloxane, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Lauroyl Lysine, Hydrogenated Lecithin, Lecithin, Maltodextrin, PEG-100 stearate, Palmaria Palmata (red seaweed) extract, Phenoxyethanol, Phenenthyl Alcohol, Polysorbate, Royal Jelly, Royal Jelly Powder, Silica, Sorbitan Isostearate, Styrene/Acrylates Copolymer, Tetrapeptide-45 , Theobroma Cacao (Cocoa) Seed Extract, Water/Aqua, Yeast Extract

PRINCIPAL DISPLAY PANEL

Jafra Royal

Royal Jelly

Luna Bright

Contains 4 samples

1 Refining Gel Cleanser

7.5ml .25 FL OZ

1 Brightening Hydrogel Moisturizer

7.5ml .25 FL OZ

1 Brightening Serum Concentrate

7.5ml .25 FL OZ

1 Brightening Daily Protector Broad SpectrumSPF 30

7.5ml .25 FL OZ

Total Contents 30ml 1 FL OZ

INGREDIENTS AND APPEARANCE

JAFRA ROYAL LUNA BRIGHT KIT 
avobenzone, homosalate, octisalate, octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-285

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-285-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	01/09/2019

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

Part 1 of 4

BRIGHTENING SERUM CONCENTRATE 
other skin care preparations

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
INGR	1,2-HEXANEDIOL (UNII: TR046Y3K1G)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	TRIDECETH-6 (UNII: 3T5PCR2H0C)
INGR	PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	DULSE (UNII: 7832HOY4ZQ)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	TREHALOSE (UNII: B8WCK70T7I)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
INGR	UREA (UNII: 8W8T17847W)
INGR	TRIACETIN (UNII: XHX3C3X673)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	EDETATE TRISODIUM (UNII: 420IP921MB)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	ROYAL JELLY (UNII: L497I37F0C)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
INGR	BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
INGR	.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
INGR	.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
INGR	HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	LINALOOL, (+)- (UNII: F4VNO44C09)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.5 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
Cosmetic

Part 2 of 4

BRIGHTENING HYDROGEL MOISTURIZER 
face and neck (excluding shaving preparations)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	DULSE (UNII: 7832HOY4ZQ)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	CYCLOMETHICONE 6 (UNII: XHK3U310BA)
INGR	SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	TREHALOSE (UNII: B8WCK70T7I)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
INGR	UREA (UNII: 8W8T17847W)
INGR	TRIACETIN (UNII: XHX3C3X673)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
INGR	DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
INGR	BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	ROYAL JELLY (UNII: L497I37F0C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.5 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
Cosmetic

Part 3 of 4

REFINING GEL CLEANSER 
face and neck (excluding shaving preparations)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
INGR	PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
INGR	COCO GLUCOSIDE (UNII: ICS790225B)
INGR	SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)
INGR	CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
INGR	GLYCOL STEARATE (UNII: 0324G66D0E)
INGR	WINE GRAPE JUICE (UNII: JHQ6158A7R)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	MICA (UNII: V8A1AW0880)
INGR	BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
INGR	CARMINIC ACID (UNII: CID8Z8N95N)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	ROYAL JELLY (UNII: L497I37F0C)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
INGR	BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
INGR	.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
INGR	.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
INGR	HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	LINALOOL, (+)- (UNII: F4VNO44C09)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.5 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
Cosmetic

Part 4 of 4

BRIGHTENING DAILY PROTECTOR BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octisalate, octocrylene jelly

Product Information
Item Code (Source)	NDC: 68828-286
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
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
LAUROYL LYSINE (UNII: 113171Q70B)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
ARGININE (UNII: 94ZLA3W45F)
LEVOMENOL (UNII: 24WE03BX2T)
SHEA BUTTER (UNII: K49155WL9Y)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CHLORPHENESIN (UNII: I670DAL4SZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALLANTOIN, (+)- (UNII: XDK458E1J9)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ISOHEXADECANE (UNII: 918X1OUF1E)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PEG-100 STEARATE (UNII: YD01N1999R)
DULSE (UNII: 7832HOY4ZQ)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ROYAL JELLY (UNII: L497I37F0C)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEG-20 SORBITAN ISOSTEARATE (UNII: X958PZJ9ON)
COCOA (UNII: D9108TZ9KG)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-286-01	7.5 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 final	part352

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/09/2019

Labeler - JAFRA COSMETICS INTERNATIONAL INC (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-285, 68828-286)