Label: ROYAL JELLY DEFY AGE AND POLLUTION PROTECTOR BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene kit
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-410-01, 68828-411-01, 68828-411-02 - Packager: Jafra cosmetics International
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 11, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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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.
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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
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INGREDIENTS AND APPEARANCE
ROYAL JELLY DEFY AGE AND POLLUTION PROTECTOR BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene kitProduct 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 creamProduct 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 creamProduct 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 creamProduct 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 lotionProduct 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)
