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| Product NDC Code | 83127-101 | ||||||
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| Drug Name | Aramore multi-defense sunscreen - am broad spectrum spf 30 |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LOTION | ||||||
| Application Number | M020 | ||||||
| Labeler Name | New Frontier Bio, Inc | ||||||
| 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 INGREDIENT ZINC OXIDE 20%
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. USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. REAPPLY AT LEAST EVERY 2 HOURS. 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, Dimethicone, Glycerin, Cetearyl Alcohol, Polymethylsilsesquioxane, Propanediol, Coco-Glucoside, Sodium Hyaluronate, Ferulic Acid, Linoleic Acid, Linolenic Acid, Niacinamide, Bisabolol, Rutin, Tocopherol, Hydroxyacetophenone, Butyrospermum Parkii (Shea) Butter, Citrus Paradisi (Grapefruit) Peel Extract, Zingiber Officinale (Ginger) Root Extract, Ipomoea Batatas Root Extract, Oryza Sativa Hull Extract, Camellia Sinensis Leaf Extract, Lactobacillus Ferment Lysate, Saccharomyces Lysate, Sodium Stearoyl Glutamate, Tetrasodium Glutamate Diacetate, Polyglyceryl-3 Ricinoleate, Polyhydroxystearic Acid, Isostearic Acid, Glyceryl Caprylate, Cetearyl Glucoside, Decyl Glucoside, Glyceryl Oleate Citrate, Lecithin, Pullulan, Xanthan Gum, Sclerotium Gum, Polysilicone-11, Sodium Hydroxide, 1,2-Hexanediol, Pentylene Glycol, Caprylyl Glycol, Sodium Benzoate, Caprylhydroxamic Acid, Ethylhexyl Palmitate.
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.USE 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.ARAMORE MULTI-DEFENSE SUNSCREEN - AM BROAD SPECTRUM SPF 30 ZINC OXIDE MEDIUM-CHAIN TRIGLYCERIDES TETRASODIUM GLUTAMATE DIACETATE POLYGLYCERYL-3 PENTARICINOLEATE ISOSTEARIC ACID PULLULAN XANTHAN GUM BETASIZOFIRAN CAPRYLYL GLYCOL SODIUM BENZOATE PROPANEDIOL NIACINAMIDE RUTIN HYDROXYACETOPHENONE SHEA BUTTER GRAPEFRUIT PEEL RICE GERM GREEN TEA LEAF DECYL GLUCOSIDE 1,2-HEXANEDIOL PENTYLENE GLYCOL LIMOSILACTOBACILLUS FERMENTUM COCO GLUCOSIDE HYALURONATE SODIUM LINOLENIC ACID SODIUM STEAROYL GLUTAMATE POLYHYDROXYSTEARIC ACID (2300 MW) GLYCERYL CAPRYLATE CAPRYLHYDROXAMIC ACID ETHYLHEXYL PALMITATE ZINC OXIDE ZINC OXIDE CETOSTEARYL ALCOHOL POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) LINOLEIC ACID TOCOPHEROL CETEARYL GLUCOSIDE LECITHIN, SOYBEAN SODIUM HYDROXIDE WATER GLYCERIN DIMETHICONE FERULIC ACID .ALPHA.-BISABOLOL, (+/-)- GINGER SWEET POTATO SACCHAROMYCES LYSATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) GLYCERYL MONOOLEATE CITRATE
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.Aramore Packaging
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.
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