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| Product NDC Code | 84436-0001 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Hydrasheer mineral sunscreen |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LOTION | ||||||
| Application Number | M020 | ||||||
| Labeler Name | THE OUTSET GROUP LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS ZINC OXIDE 14.93% …
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USES HELPS PREVENT SUNBURN
Purpose
Information about the drug product’s indications for use.PURPOSE ..... SUNSCREEN
Spl product data elements
Usually a list of ingredients in a drug product.HYDRASHEER MINERAL SUNSCREEN ZINC OXIDE DIPROPYLENE GLYCOL SODIUM HYDROXIDE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE NIACINAMIDE TRIETHOXYCAPRYLYLSILANE ISOSTEARIC ACID TOCOPHEROL 1,2-HEXANEDIOL POLYHYDROXYSTEARIC ACID (2300 MW) ALLANTOIN ZINC OXIDE ZINC OXIDE WATER ISONONYL ISONONANOATE PONGAMIA PINNATA SEED CERAMIDE NP TRISODIUM ETHYLENEDIAMINE DISUCCINATE GLYCERIN LAURYL GLUCOSIDE POTASSIUM CETYL PHOSPHATE ETHYLHEXYL METHOXYCRYLENE ARGANIA SPINOSA SEED BENZOTRIAZOLYL DODECYL P-CRESOL PHENOXYETHANOL PROPANEDIOL DICAPRYLYL CARBONATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.image of label
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API