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| Product NDC Code | 84100-0001 | ||||
|---|---|---|---|---|---|
| Drug Name | Mineral sunscreen spf 50 broad spectrum |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Figure 1 Beauty, Inc. | ||||
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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 INGREDIENT ZINC OXIDE 18.76% ….
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 SHAKE WELL BEFORE USE. APPLY LIBERALLY AND EVENLY 15 MINUTES BEFORE SUN EXPOSURE. REAPPLY AT LEAST EVERY 2 HOURS APPLY TO ALL SKIN EXPOSED TO THE SUN. CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR. 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 Water (Aqua), Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Squalane, Butyloctyl Salicylate, Polymethylsilsesquioxane, Copernicia Cerifera (Carnauba) Wax, Coconut Alkanes, Dimethicone, Propanediol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Diisostearate, Caprylyl Methicone, Argania Spinosa Kernel Oil, Ethylhexyl Methoxycrylene, Tocopheryl Acetate, Glycerin, Isododecane, Limnanthes Alba (Meadowfoam) Seed Oil, Plankton Extract, Micrococcus Lysate, Hydrolyzed Hyaluronic Acid, Pongamia Pinnata Seed Extract, Oryza Sativa (Rice) Bran Wax, Lecithin, Tocopherol, Sodium Chloride, Magnesium Chloride, Coco-Caprylate/Caprate, Xanthan Gum, Stearalkonium Hectorite, Glyceryl Caprylate, Bisabolol, Polysilicone-11, Polyhydroxystearic Acid, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxycaprylylsilane, Propylene Carbonate, Caprylhydroxamic Acid, Hydroxyacetophenone, Phenethyl Alcohol
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 If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
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.Mineral Sunscreen SPF 50 Broad Spectrum ZINC OXIDE MAGNESIUM CHLORIDE BUTYLOCTYL SALICYLATE GLYCERYL CAPRYLATE ZINC OXIDE ZINC OXIDE ETHYLHEXYL METHOXYCRYLENE TOCOPHEROL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE ISODODECANE WATER PROPANEDIOL POLYGLYCERYL-3 DIISOSTEARATE GLYCERIN SQUALANE DIMETHICONE COCONUT ALKANES POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE TRIETHOXYCAPRYLYLSILANE STEARALKONIUM HECTORITE PONGAMIA PINNATA SEED SODIUM CHLORIDE CAPRYLHYDROXAMIC ACID XANTHAN GUM COCO-CAPRYLATE/CAPRATE PROPYLENE CARBONATE HYDROXYACETOPHENONE
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 carton
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. SUITABLE FOR: ALL SKIN TYPES.
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