Label: HAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA- avobenzone, octinoxate, octisalate, oxybenzone jelly
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-124-01, 68828-124-02 - Packager: JAFRA COSMETICS INTERNATIONAL
- Category: HUMAN OTC DRUG LABEL
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 15, 2019
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ACTIVE INGREDIENT
Active Ingredients Purpose
Avobenzone 3% Sunscreen
Octinoxate 7.5% Sunscreen
Octisalate 5% Sunscreen
Oxybenzone 2% Sunscreen
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. If product is swallowed, get medical help or contact a Poison Control Cneter right away.
Stop use and ask a doctor if rash occurs
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.
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: 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 sunscreen measures including:
limit time in the sun, especially from 10a.m.- 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses
Inactive
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, Ethylhexyglycerin, Methylisothiazolinone, Royal Jelly, Helianthus Annuus (Sunflower) Sprout Extract, Lecithin, Hydrolyzed Myrtus Communis Leaf Extract, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Trisodium EDTA
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INGREDIENTS AND APPEARANCE
HAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA
avobenzone, octinoxate, octisalate, oxybenzone jellyProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 75 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 75 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 75 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g in 75 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) PANTHENOL (UNII: WV9CM0O67Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) ROYAL JELLY (UNII: L497I37F0C) HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) PEG-4 LAURATE (UNII: AYF4VM3N1Z) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) EDETATE TRISODIUM (UNII: 420IP921MB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-124-02 1 in 1 CARTON 02/13/2013 1 NDC:68828-124-01 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 02/13/2013 Labeler - JAFRA COSMETICS INTERNATIONAL (041676479) Registrant - JAFRA COSMETICS INTERNATIONAL (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-124)
