Label: ROYAL JELLY HAND COMPLEX BROAD SPECTRUM SPF 15- avobenzone, octinoxate, octisalate, oxybenzone lotion
- NDC Code(s): 68828-753-01
- Packager: JAFRA COSMETICS INTERNATIONAL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 May 11, 2022
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- Active Ingredient(s)
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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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/Aqua, Polyglyceryl-3 Methylglucose Distearate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Glyceryl Stearate, Glycerin, Panthenol, Tocopheryl Acetate, Withania Somnifera (Winter Cherry) Extract, Nelumbo Nucifera (Lotus) Extract, Fragrance/Parfum, Royal Jelly, Helianthus Annuus (Sunflower) Sprout Extract, Lecithin, Hydrolyzed Myrtus Communis Leaf Extract, PEG-4 Laurate, Iodopropynyl Butylcarbamate, DMDM Hydantoin, Diazolidinyl Urea, Trisodium EDTA, Coumarin, Eugenol, Geraniol, Citronellol, Hexyl Cinnamal, Butylphenyl Methylpropional, Linalool, Alpha-Isomethyl Ionone
- Other information
- Product label
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INGREDIENTS AND APPEARANCE
ROYAL JELLY HAND COMPLEX BROAD SPECTRUM SPF 15
avobenzone, octinoxate, octisalate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-753 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) PANTHENOL (UNII: WV9CM0O67Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WITHANIA SOMNIFERA ROOT (UNII: V038D626IF) ROYAL JELLY (UNII: L497I37F0C) HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) PEG-4 LAURATE (UNII: AYF4VM3N1Z) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) DMDM HYDANTOIN (UNII: BYR0546TOW) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) EDETATE TRISODIUM (UNII: 420IP921MB) COUMARIN (UNII: A4VZ22K1WT) EUGENOL (UNII: 3T8H1794QW) GERANIOL (UNII: L837108USY) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) LINALOOL, (+/-)- (UNII: D81QY6I88E) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-753-01 1 in 1 CARTON 01/11/2022 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 not final part352 01/11/2022 Labeler - JAFRA COSMETICS INTERNATIONAL (041676479) Registrant - JAFRA COSMETICS INTERNATIONAL (041676479) Establishment Name Address ID/FEI Business Operations Distribuidora Comercial Jafra, S.A. de C.V. 951612777 manufacture(68828-753)
