ROYAL JELLY DEFY AGE AND POLLUTION PROTECTOR BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene kit

Royal Jelly Defy Age and pollution protector Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Royal Jelly Defy Age and pollution protector Broad Spectrum SPF 50 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 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 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 generously and evenly 15 minutes before sun exposure

Use a water-resistant sunscreen if swimming or sweating

Reapply at least every 2 hours.

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

Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT

Inactive ingredients

Alumina, Butylene Glycol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide 3, Cerium Oxide, Dipropylene Glycol, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Glycine Soja (Soybean) Seed Extract, Hexylene Glycol, Hydrogenated Lecithin, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyltaurate Copolymer, Lecithin, Maltodextrin, Olea Europaea (Olive) Fruit Oil, PEG-100 Stearate, Persea Gratissima (Avocado) Oil, Phenethyl Alcohol, Phenoxyethanol, Phytosterols, Polyester-8, Polymethyl Methacrylate, Polysorbate 60, Potassium Sorbate, Royal Jelly Powder, Royal Jelly, Sodium Benzoate, Sodium Hyaluronate, Sodium PCA, Squalane, Styrene/Acrylates Copolymer, Sucrose Stearate, Tetrapeptide-45, Theobroma Cacao (Cocoa) Seed Extract, Tocopherol, Tocopheryl Acetate, Tuber Magnatum Extract, VP/Eicosene Copolymer, Water/Aqua, Xanthan Gum

PRINCIPAL DISPLAY PANEL

Jafra Royal Jelly

Defy

Age & Pollution Protector Broad Spectrum SFP 50

50 ml 1.7 Fl Oz

INGREDIENTS AND APPEARANCE

ROYAL JELLY DEFY AGE AND POLLUTION PROTECTOR BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-410

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-410-01	1 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	07/11/2019

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

Part 1 of 4

ACTIVE FIRMING SERUM 
lotions, oils, powders, and creams cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)
INGR	LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	METHYL GLUCETH-20 (UNII: J3QD0LD11P)
INGR	ACETYL TETRAPEPTIDE-11 (UNII: 0R3VC3BV8I)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	ACETYL TETRAPEPTIDE-9 (UNII: VMO8OOD3V0)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	HYALURONIC ACID (UNII: S270N0TRQY)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	BENZYL SALICYLATE (UNII: WAO5MNK9TU)
INGR	BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
INGR	ROYAL JELLY (UNII: L497I37F0C)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	SOYBEAN (UNII: L7HT8F1ZOD)
INGR	CERAMIDE NP (UNII: 4370DF050B)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	AVOCADO OIL (UNII: 6VNO72PFC1)
INGR	OLIVE OIL (UNII: 6UYK2W1W1E)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
INGR	POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	CAFFEINE (UNII: 3G6A5W338E)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	WATER (UNII: 059QF0KO0R)
INGR	DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
INGR	DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		07/12/2019

Part 2 of 4

4D DEFINING HYDRATOR 
lotions, oils, powders, and creams cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	WATER (UNII: 059QF0KO0R)
INGR	XYLITOL (UNII: VCQ006KQ1E)
INGR	XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
INGR	OCTYLDODECANOL (UNII: 461N1O614Y)
INGR	PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	C18-C21 ALKANE (UNII: 33822S0M40)
INGR	ANHYDROXYLITOL (UNII: 8XWR7NN42F)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	ETHYLHEXYL PALMITATE (UNII: 2865993309)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	SOYBEAN (UNII: L7HT8F1ZOD)
INGR	CERAMIDE NP (UNII: 4370DF050B)
INGR	AVOCADO OIL (UNII: 6VNO72PFC1)
INGR	HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
INGR	PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	JOJOBA OIL (UNII: 724GKU717M)
INGR	CERAMIDE NG (UNII: C04977SRJ5)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	TRIBEHENIN (UNII: 8OC9U7TQZ0)
INGR	DEXTRAN 1 (UNII: I8LHQ0D645)
INGR	ROYAL JELLY (UNII: L497I37F0C)
INGR	AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	BENZYL SALICYLATE (UNII: WAO5MNK9TU)
INGR	MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
INGR	CAFFEINE (UNII: 3G6A5W338E)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	OLIVE OIL (UNII: 6UYK2W1W1E)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		07/12/2019

Part 3 of 4

RICH CREME CLEANSER 
lotions, oils, powders, and creams cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	ISOHEXADECANE (UNII: 918X1OUF1E)
INGR	CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	ROYAL JELLY (UNII: L497I37F0C)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	OLIVE OIL (UNII: 6UYK2W1W1E)
INGR	SOYBEAN (UNII: L7HT8F1ZOD)
INGR	CERAMIDE NP (UNII: 4370DF050B)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	PEG-100 STEARATE (UNII: YD01N1999R)
INGR	STEARYL HEPTANOATE (UNII: 2M4UGL1NCN)
INGR	STEARYL CAPRYLATE (UNII: 06TS6O9194)
INGR	HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	POLYSORBATE 60 (UNII: CAL22UVI4M)
INGR	SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	AVOCADO OIL (UNII: 6VNO72PFC1)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2		7.5 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		07/12/2019

Part 4 of 4

ROYAL JELLY DEFY AGE AND POLLUTION PROTECTOR BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Item Code (Source)	NDC: 68828-411
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
CERIC OXIDE (UNII: 619G5K328Y)
ALUMINUM OXIDE (UNII: LMI26O6933)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
CERAMIDE NP (UNII: 4370DF050B)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
AVOCADO OIL (UNII: 6VNO72PFC1)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
WATER (UNII: 059QF0KO0R)
COCOA (UNII: D9108TZ9KG)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SQUALANE (UNII: GW89575KF9)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOYBEAN (UNII: L7HT8F1ZOD)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ROYAL JELLY (UNII: L497I37F0C)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SHEA BUTTER (UNII: K49155WL9Y)
OLIVE OIL (UNII: 6UYK2W1W1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-411-01	14 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2	NDC: 68828-411-02	7.5 mL in 1 BOTTLE; 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	07/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/11/2019

Labeler - Jafra cosmetics International (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-410, 68828-411)