Label: JAFRA ROYAL MEN SAMPLE SET- avobenzone, homosalate kit
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-395-01, 68828-396-01 - Packager: Jafra International Cosmetics
- 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 April 8, 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 liberally 15 minutes before sun exposure
- Reapply: after 80 minutes of swimming or sweating
- Immediately after towel drying
- 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 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10a.m. – 2p.m.
Wear long-sleeve shirts, pants, hats, and sunglasses -
INACTIVE INGREDIENT
INGREDIENTS/INGREDIENTES: Water/Aqua, Glycerin, Cetearyl Alcohol, Ceteareth-20, Sodium Pca, Stearyl Stearate, Heptyl Undecylenate, C13-16 Isoparaffin, Dimethicone, Royal Jelly Powder, lecithin, Dipropylene Glycol, Royal Jelly, Tetrapeptide-45, Hydrogenated Lecithin, Sodium Hyaluronate, Hydroxyethyl Urea, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin,
Hexylene Glycol, Hydrolyzed Myrtus Communis Leaf Extract, Butylene Glycol, Rosa Canina Fruit Extract,
Palmaria Palmata (Red Seaweed) Extract, Triethanolamine, Myristyl Myristate, Sodium Acrylates Crosspolymer-2, Bis-Diglyceryl Polyacyladipate-2, Salix Alba (Willow) Bark Extract, Bisabolol, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Panthenol, Caffeine, Tocopheryl Acetate, Fragrance/Parfum, Butylphenyl Methylpropional (Lillial), Citral, Citronellol, Coumarin, Limonene, Linalool, Butyrospermum Parkii (Shea) Butter, Phenethyl Alcohol, Maltodextrin, Quercus Petraea Fruit Extract, Trisodium Edta. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JAFRA ROYAL MEN SAMPLE SET
avobenzone, homosalate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-395 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-395-01 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 04/09/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 JAR 7.5 mL in 100 Part 2 1 JAR 7.5 mL in 100 Part 3 1 JAR 25 mL in 100 Part 4 1 JAR 7.5 mL in 100 Part 1 of 4 3-IN-1 FACE MOISTURIZER BROAD SPECTRUM SPF 20
avobenzone, homosalate, octisalate, octocrylene creamProduct Information Item Code (Source) NDC:68828-396 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) LEVOMENOL (UNII: 24WE03BX2T) C13-16 ISOPARAFFIN (UNII: LED42LZG6O) CAFFEINE (UNII: 3G6A5W338E) GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) TRIACETIN (UNII: XHX3C3X673) UREA (UNII: 8W8T17847W) WATER (UNII: 059QF0KO0R) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) PEG-100 STEARATE (UNII: YD01N1999R) TREHALOSE (UNII: B8WCK70T7I) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) COCOA (UNII: D9108TZ9KG) MALTODEXTRIN (UNII: 7CVR7L4A2D) PHENOXYETHANOL (UNII: HIE492ZZ3T) SALIX ALBA BARK (UNII: 205MXS71H7) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HEPTYL UNDECYLENATE (UNII: W77QUB6GXO) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) ARGININE (UNII: 94ZLA3W45F) DOCOSANOL (UNII: 9G1OE216XY) CITRAL (UNII: T7EU0O9VPP) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) COUMARIN (UNII: A4VZ22K1WT) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) ALLANTOIN (UNII: 344S277G0Z) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) SHEA BUTTER (UNII: K49155WL9Y) DIPROPYLENE GLYCOL (UNII: E107L85C40) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) LAUROYL LYSINE (UNII: 113171Q70B) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-396-01 7.5 mL in 1 JAR; 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 04/09/2019 Part 2 of 4 CLEAN AND CONDITION FACE WASH
face and neck (excluding shaving preparations) creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR GLYCERIN (UNII: PDC6A3C0OX) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR COCO GLUCOSIDE (UNII: ICS790225B) INGR COUMARIN (UNII: A4VZ22K1WT) INGR DEHYDROACETIC ACID (UNII: 2KAG279R6R) INGR BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) INGR CAFFEINE (UNII: 3G6A5W338E) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR SALIX ALBA BARK (UNII: 205MXS71H7) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR ROYAL JELLY (UNII: L497I37F0C) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR BENZOIC ACID (UNII: 8SKN0B0MIM) INGR SODIUM METHYL OLEOYL TAURATE (UNII: 8PZ076134H) INGR LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) INGR WATER (UNII: 059QF0KO0R) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR CITRAL (UNII: T7EU0O9VPP) INGR HYDROXYCITRONELLOL (UNII: R0B4U2I48W) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.5 mL in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 04/09/2019 Part 3 of 4 POST SHAVE FACE TONIC
preshave lotions (all types) liquidProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR ROYAL JELLY (UNII: L497I37F0C) INGR SALICYLIC ACID (UNII: O414PZ4LPZ) INGR CAFFEINE (UNII: 3G6A5W338E) INGR LEVOMENOL (UNII: 24WE03BX2T) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR SALIX ALBA BARK (UNII: 205MXS71H7) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR TRIACETIN (UNII: XHX3C3X673) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR TROLAMINE (UNII: 9O3K93S3TK) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P) INGR EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR ALCOHOL (UNII: 3K9958V90M) INGR TREHALOSE (UNII: B8WCK70T7I) INGR POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) INGR UREA (UNII: 8W8T17847W) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 25 mL in 1 JAR; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 04/09/2019 Part 4 of 4 AGE DEFENSE FACE HYDRATOR
face and neck (excluding shaving preparations) jellyProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J) INGR ROSA CANINA FRUIT (UNII: 3TNW8D08V3) INGR TROLAMINE (UNII: 9O3K93S3TK) INGR BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR DULSE (UNII: 7832HOY4ZQ) INGR LEVOMENOL (UNII: 24WE03BX2T) INGR CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) INGR CAFFEINE (UNII: 3G6A5W338E) INGR CITRAL (UNII: T7EU0O9VPP) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR ROYAL JELLY (UNII: L497I37F0C) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR MYRISTYL MYRISTATE (UNII: 4042ZC00DY) INGR WATER (UNII: 059QF0KO0R) INGR HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR SALIX ALBA BARK (UNII: 205MXS71H7) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR STEARYL STEARATE (UNII: 5WX2EGD0DK) INGR HEPTYL UNDECYLENATE (UNII: W77QUB6GXO) INGR C13-16 ISOPARAFFIN (UNII: LED42LZG6O) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) INGR .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) INGR COUMARIN (UNII: A4VZ22K1WT) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR EDETATE TRISODIUM (UNII: 420IP921MB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.5 mL in 1 JAR; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 04/09/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/09/2019 Labeler - Jafra International Cosmetics (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-395, 68828-396)
