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| Product NDC Code | 81545-101 | ||||
|---|---|---|---|---|---|
| Drug Name | Mineral sunscreen spf 30 |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | part352 | ||||
| Labeler Name | Lee Indie & Co 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 Shake before use. Apply generously to skin 15 minutes before sun exposure. During sun exposure, reapply: After 40 minutes of swimming or sweating Immediately after towel drying At least every two hours Sun Protection Measures Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. to 4 p.m.; wear long sleeve shirts, pants, hats and sunglasses. Children under 6 months: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Water (aqua), Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Squalane, Dicapryl Carbonate, Cetearyl Olivate, Sorbitan Olivate, Glycerin, Shea Butter Cetyl Esters, Sorbitan Sesquioleate, Polyhydroxystearic Acid, Diglycerin, Pinus Pinaster (Cluster Pine) Bark Extract, Punica Granatum (Pomegranate) Seed Oil, Phenethyl Alcohol, Pentylene Glycol, Propanediol, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Panthenol, Xanthan Gum, Lauroyl Lysine
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 30 ZINC OXIDE MARITIME PINE POMEGRANATE SEED OIL ALOE VERA LEAF PANTHENOL XANTHAN GUM PHENYLETHYL ALCOHOL PENTYLENE GLYCOL PROPANEDIOL LAUROYL LYSINE MEDIUM-CHAIN TRIGLYCERIDES SORBITAN OLIVATE WATER SUNFLOWER OIL GLYCERIN SQUALANE DICAPRYLYL CARBONATE CETEARYL OLIVATE ZINC OXIDE ZINC CATION DIGLYCERIN SHEA BUTTER ETHYL ESTERS SORBITAN SESQUIOLEATE POLYHYDROXYSTEARIC ACID (2300 MW)
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.0-LBL (PDP)_Mineral Sunscreen 0-LBL (back)_Mineral Sunscreen
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS OR COMMENTS? INDIELEE.COM +1 (866) 488-1638 MON-FRI (9 A.M. - 5 P.M. EST)
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION Protect this product from excessive heat and direct sun. Store below 90°F (32°C).
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 CONSULT A PHYSICIAN 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