Otc - Active Ingredient
ACTIVE INGREDIENTS
ZINC OXIDE 14.93% …
Hydrasheer Mineral Sunscreen Lotion
FDA Label NDC 84436-0001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Outset Group Llc for the product Hydrasheer Mineral Sunscreen (NDC 84436-0001). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PURPOSE
..... SUNSCREEN
Indications & Usage
USES
- HELPS PREVENT SUNBURN
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.
• 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.
Dosage & Administration
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 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
Storage And Handling
OTHER INFORMATION
• PROTECT THE PRODUCT IN THIS
CONTAINER FROM EXCESSIVE HEAT
AND DIRECT SUN
Inactive Ingredient
INACTIVE INGREDIENTS
AQUA/WATER/EAU, ISONONYL ISONONANOATE, PROPANEDIOL, ARGANIA SPINOSA KERNEL OIL, TOCOPHERYL ACETATE, DICAPRYLYL CARBONATE, LAURYL GLUCOSIDE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, 1,2-HEXANEDIOL, POTASSIUM CETYL PHOSPHATE, HYDROGENATED LECITHIN, GLYCERIN, NIACINAMIDE, TREMELLA FUCIFORMIS SPOROCARP EXTRACT, HELIANTHUS ANNUUS SUNFLOWER SEED OIL, CASSIA ANGUSTIFOLIA SEED POLYSACCHARIDE, CANDIDA BOMBICOLA/GLUCOSE/METHYL RAPESEEDATE FERMENT, PONGAMIA PINNATA SEED EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, CERAMIDE NP, CETEARYL ALCOHOL, POLYHYDROXYSTEARIC ACID, SILICA, ETHYLHEXYL METHOXYCRYLENE, TRIETHOXYCAPRYLYLSILANE, COCO-CAPRYLATE CAPRATE, COCO-GLUCOSIDE, TRIHEPTANOIN, HYDROXYACETOPHENONE, XANTHAN GUM, BISABOLOL,CAPRYLIC/CAPRIC TRIGLYCERIDE, CITRIC ACID, C9-12 ALKANE, DILINOLEIC ACID BUTANEDIOL COPOLYMER, ALLANTOIN, BENZOTRIAZOLYL DODECYL P-CRESOL, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, ISOSTEARIC ACID, PHENOXYETHANOL, DIPROPYLENE GLYCOL, LECITHIN, POLYGLYCERYL-3 POLYRICINOLEATE, HYDROXYETHYLCELLULOSE, CASTOR OIL IPDI COPOLYMER, SODIUM HYDROXIDE, TOCOPHEROL
Package Label.Principal Display Panel
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