Active Ingredient
ZINC OXIDE
Brighter Day Broad Spectrum
FDA Label NDC 82495-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sqn Lab for the product Brighter Day Broad Spectrum (NDC 82495-101). 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 active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
SUNSCREEN
Use
HELPS PREVENT SUNBURN
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.
STOP USE AND ASK A DOCTOR IF RASH OCCURS.
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 CENTER RIGHT AWAY.
Directions
- APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
- CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.
- USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
- REAPPLY AT LEAST EVERY 2 HOURS.
- SUN PROTECTION MEASURES.
SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY AGING. TO DECREASE THE RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING: - LIMIT TIME IN THE SUN, ESPECIALLY FROM 10:00 A.M. - 2 P.M.
- WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
Inactive Ingredients
WATER, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIETHYLHEXYL 2,6-NAPHTHALATE, HYDROXYETHYL ACRYLATE/SODIUM, ACRYLOYLDIMETHYL TAURATE COPOLYMER, SODIUM OLIVATE, XYLITYLGLUCOSIDE, ANHYDROXYLITOL, TRIETHOXYCAPRYLYLSILANE, XYLITOL,PENTYLENE GLYCOL, CITRIC ACID, TOCOPHEROL, CAMELLIA SINENSIS LEAF OIL, DIMETHICONE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, IRON OXIDES.
Other Information
- PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
* Please review the disclaimer below.
