Otc - Active Ingredient
Active Ingredients Purpose
Avobenzone 3% Sunscreen
Octinoxate 7.5% Sunscreen
Octisalate 5% Sunscreen
Oxybenzone 2% Sunscreen
Hand Complex Broad Spectrum Spf 15
FDA Label NDC 68828-124
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jafra Cosmetics International for the product Hand Complex Broad Spectrum Spf 15 (NDC 68828-124). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Cneter right away.
Indications & Usage
Stop use and ask a doctor if rash occurs
Warnings
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.
Dosage & Administration
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 Ingredient
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
Package Label.Principal Display Panel
Carton Front (Front)
Carton Back (Back)
Jafra
Royal Jelly
with/con
Cellspan Complex
Hand Complex Broad Spectrum SPF 15
Cont. Net. 75 ml 2.5 fl oz (US)
* Please review the disclaimer below.
