Active Ingredient
ZINC OXIDE 20%
Aramore Multi-defense Sunscreen - Am Lotion
FDA Label NDC 83127-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by New Frontier Bio, Inc for the product Aramore Multi-defense Sunscreen - Am (NDC 83127-101). 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, other information, inactive ingredients, 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 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 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 TIME IN THE SUN, ESPECIALLY FROM 10 A.M. - 2 P.M.
- WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
Other Information
- PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
Inactive Ingredients
Water, Butylene Glycol, Caprylic / Capric Triglyceride, Dimethicone, Cetearyl Alcohol, Cetearyl Olivate, Polyglyceryl-3 Diisostearate, Sorbitan Olivate, Cetearyl Glucoside, Triethoxycaprylylsilane, Camellia Sinensis (Green Tea) Leaf Oil, Tocopheryl Acetate, Xanthan
Gum, Triethoxycaprylylsilanea, Phenoxyethanol, Ethylhexylglycerin, Iron Oxides
* Please review the disclaimer below.
