Active Ingredient
ZINC OXIDE 10%
Age Reset Restore Plus Protect Day Cream Lotion
FDA Label NDC 76286-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Skinn Cosmetics, Llc for the product Age Reset Restore Plus Protect Day Cream (NDC 76286-101). 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.
- SUNPROTECTION MEASURES: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY AGING. TO DECREASE THE RISK, REGULARLY USE 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 (Aqua), Butylene Glycol, Dimethicone, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Polyglyceryl-3 Diisostearate, Sorbitan Olivate, Terminalia Chebula Fruit Extract, Ascorbic Acid, Tocopherol, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Glycerin, Sodium Lactate, Cetearyl Glucoside, Xanthan Gum, Polysorbate 20, Carbomer, Triethoxycaprylylsilane, Phenoxyethanol, Ethylhexylglycerin, Iron Oxides.
Package Label.Principal Display Panel
Skinn Spf Pdp (Skinn Spf30 Pdp Final)
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