FDA Label for Essential Daily Sunscreen
View Indications, Usage & Precautions
Essential Daily Sunscreen Product Label
The following document was submitted to the FDA by the labeler of this product Antedotum Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
ZINC OXIDE 10%
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.
- REAPPLY AT LEAST EVERY 2 HOURS.
- USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
- SUN PROTECTION 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, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE, CETEARYL ALCOHOL, CETEARYL OLIVATE, POLYGLYCERYL-3 DIISOSTEARATE, SORBITAN OLIVATE, TOCOPHEROL, POPULUS TREMULOIDES (ASPEN) BARK EXTRACT, TETRAHEXYLDECYL ASCORBATE, CITRUS AURANTIUM AMARA (BITTER ORANGE)FLOWER OIL, HYDROLYZED PEA PROTEIN, GLYCERIN, GLUCOSE, CETEARYL GLUCOSIDE, TRIETHOXYCAPRYLYLSILANE, SODIUM CHLORIDE, SODIUM SUCCINATE, XANTHAN GUM, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL, IRON OXIDES.
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