Label: ROYAL MEN SAMPLE SET- avobenzone, homosalate, octisalate, octocrylene kit
ROYAL MEN 3-IN-1 FACE MOISTURIZER BROAD SPECTRUM SPF 20- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 68828-765-01, 68828-766-01, 68828-767-01
- Packager: Jafra International Cosmetics
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 5, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
-
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
Water, Glycerin, Dimethicone, Styrene/Acrylates Copolymer, Silica, Aluminum Starch Octenylsuccinate, Butyloctyl Salicylate, Heptyl Undecylenate, Polyester-8, Phenoxyethanol, Glyceryl Stearate, PEG-100 Stearate, C13-16 Isoparaffin, Lauroyl Lysine, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Royal Jelly Powder, Tetrapeptide-45, Hydrogenated Lecithin, Butyrospermum Parkii (Shea) Butter, Royal Jelly, Salix Alba (Willow) Bark Extract, Quercus Petraea Fruit Extract, Cetyl Alcohol, Ethylhexyl Methoxycrylene, Capryloyl Glycerin/Sebacic Acid Copolymer, Xanthan Gum, Sodium Hyaluronate, Trehalose, Sodium PCA, Polyquaternium-51, Urea, Triacetin, Caffeine, Allantoin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Acrylates Crosspolymer-2, Arginine, Ethylhexylglycerin, Tocopherol, Fragrance, Citronellol, Coumarin, Limonene, Linalool, Disodium EDTA, Butylene Glycol, Theobroma Cacao (Cocoa) Seed Extract, Yeast Extract, Bisabolol, Phenethyl Alcohol, Maltodextrin, Lecithin, Dipropylene Glycol
- Other information
- Product label
-
INGREDIENTS AND APPEARANCE
ROYAL MEN SAMPLE SET
avobenzone, homosalate, octisalate, octocrylene kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-765 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-765-01 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 03/09/2022 06/30/2024 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 7.5 mL in 100 Part 2 1 TUBE 7.5 mL in 100 Part 3 1 TUBE 25 mL in 100 Part 4 1 TUBE 7.5 mL in 100 Part 1 of 4 ROYAL MEN 3-IN-1 FACE MOISTURIZER BROAD SPECTRUM SPF 20
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Item Code (Source) NDC:68828-766 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 WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HEPTYL UNDECYLENATE (UNII: W77QUB6GXO) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) C13-16 ISOPARAFFIN (UNII: LED42LZG6O) LAUROYL LYSINE (UNII: 113171Q70B) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) DOCOSANOL (UNII: 9G1OE216XY) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) SHEA BUTTER (UNII: K49155WL9Y) ROYAL JELLY (UNII: L497I37F0C) SALIX ALBA BARK (UNII: 205MXS71H7) QUERCUS PETRAEA WHOLE (UNII: 45C533V2SL) CETYL ALCOHOL (UNII: 936JST6JCN) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) XANTHAN GUM (UNII: TTV12P4NEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TREHALOSE (UNII: B8WCK70T7I) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) UREA (UNII: 8W8T17847W) TRIACETIN (UNII: XHX3C3X673) CAFFEINE (UNII: 3G6A5W338E) ALLANTOIN (UNII: 344S277G0Z) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) ARGININE (UNII: 94ZLA3W45F) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TOCOPHEROL (UNII: R0ZB2556P8) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) COUMARIN (UNII: A4VZ22K1WT) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) COCOA (UNII: D9108TZ9KG) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) LEVOMENOL (UNII: 24WE03BX2T) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) MALTODEXTRIN (UNII: 7CVR7L4A2D) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) DIPROPYLENE GLYCOL (UNII: E107L85C40) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-766-01 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 OTC Monograph Drug M020 01/13/2022 06/30/2024 Part 2 of 4 CLEAN AND CONDITION FACE WASH
other skin care preparations, leave-on [skin care preparations (creams, lotions, powder, and sprays)] gelProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R) INGR SODIUM METHYL OLEOYL TAURATE (UNII: 8PZ076134H) INGR LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) INGR COCO GLUCOSIDE (UNII: ICS790225B) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR CAFFEINE (UNII: 3G6A5W338E) INGR ROYAL JELLY (UNII: L497I37F0C) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR BENZOIC ACID (UNII: 8SKN0B0MIM) INGR DEHYDROACETIC ACID (UNII: 2KAG279R6R) INGR .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) INGR COUMARIN (UNII: A4VZ22K1WT) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR SALIX ALBA BARK (UNII: 205MXS71H7) INGR QUERCUS PETRAEA WHOLE (UNII: 45C533V2SL) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 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 01/14/2022 Part 3 of 4 POST SHAVE FACE TONIC
other skin care preparations, leave-on [skin care preparations (creams, lotions, powder, and sprays)] liquidProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR ALCOHOL (UNII: 3K9958V90M) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR HAMAMELIS VIRGINIANA WHOLE (UNII: V663Q8TEFU) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 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 SALICYLIC ACID (UNII: O414PZ4LPZ) INGR ROYAL JELLY (UNII: L497I37F0C) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR TROLAMINE (UNII: 9O3K93S3TK) INGR CAFFEINE (UNII: 3G6A5W338E) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P) INGR POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR SALIX ALBA BARK (UNII: 205MXS71H7) INGR QUERCUS PETRAEA WHOLE (UNII: 45C533V2SL) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR LEVOMENOL (UNII: 24WE03BX2T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 25 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 Cosmetic 01/14/2022 Part 4 of 4 AGE DEFENSE FACE HYDRATOR
other skin care preparations, leave-on [skin care preparations (creams, lotions, powder, and sprays)] creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR STEARYL STEARATE (UNII: 5WX2EGD0DK) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR HEPTYL UNDECYLENATE (UNII: W77QUB6GXO) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) INGR C13-16 ISOPARAFFIN (UNII: LED42LZG6O) INGR ROYAL JELLY (UNII: L497I37F0C) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR ROSA CANINA FRUIT (UNII: 3TNW8D08V3) INGR PALMARIA PALMATA (UNII: 7832HOY4ZQ) INGR TROLAMINE (UNII: 9O3K93S3TK) INGR MYRISTYL MYRISTATE (UNII: 4042ZC00DY) INGR SODIUM ACRYLATES CROSSPOLYMER-2 (UNII: D3HPR4WW6F) INGR BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T) INGR SALIX ALBA BARK (UNII: 205MXS71H7) INGR LEVOMENOL (UNII: 24WE03BX2T) INGR CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL) INGR CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR CAFFEINE (UNII: 3G6A5W338E) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) INGR COUMARIN (UNII: A4VZ22K1WT) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR QUERCUS PETRAEA WHOLE (UNII: 45C533V2SL) INGR EDETATE TRISODIUM (UNII: 420IP921MB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 Cosmetic 01/14/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/09/2022 06/30/2024 ROYAL MEN 3-IN-1 FACE MOISTURIZER BROAD SPECTRUM SPF 20
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-767 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 WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HEPTYL UNDECYLENATE (UNII: W77QUB6GXO) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) C13-16 ISOPARAFFIN (UNII: LED42LZG6O) LAUROYL LYSINE (UNII: 113171Q70B) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) DOCOSANOL (UNII: 9G1OE216XY) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) SHEA BUTTER (UNII: K49155WL9Y) ROYAL JELLY (UNII: L497I37F0C) SALIX ALBA BARK (UNII: 205MXS71H7) QUERCUS PETRAEA WHOLE (UNII: 45C533V2SL) CETYL ALCOHOL (UNII: 936JST6JCN) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) XANTHAN GUM (UNII: TTV12P4NEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TREHALOSE (UNII: B8WCK70T7I) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) UREA (UNII: 8W8T17847W) TRIACETIN (UNII: XHX3C3X673) CAFFEINE (UNII: 3G6A5W338E) ALLANTOIN (UNII: 344S277G0Z) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) ARGININE (UNII: 94ZLA3W45F) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TOCOPHEROL (UNII: R0ZB2556P8) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) COUMARIN (UNII: A4VZ22K1WT) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) COCOA (UNII: D9108TZ9KG) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) LEVOMENOL (UNII: 24WE03BX2T) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) MALTODEXTRIN (UNII: 7CVR7L4A2D) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) DIPROPYLENE GLYCOL (UNII: E107L85C40) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-767-01 1 in 1 CARTON 03/09/2022 06/30/2024 1 75 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 OTC Monograph Drug M020 03/09/2022 06/30/2024 Labeler - Jafra International Cosmetics (041676479) Establishment Name Address ID/FEI Business Operations Distribuidora Comercial Jafra, S.A. de C.V. 951612777 manufacture(68828-765, 68828-766, 68828-767)
