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| Product NDC Code | 60781-4175 | ||||
|---|---|---|---|---|---|
| Drug Name | Thinkbaby clear zinc spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | thinkOperations,LLC | ||||
| Packages |
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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. Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours when exposed to sun 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 For children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Purified Water, Caprylic/Capric Triglyceride, Polyglyceryl-4 Isostearate, Glycerin, Hydrogenated Glyceryl Abietate, Hexyl Laurate, Cetyl Dimethicone, Sorbitan Sesquioleate, Aloe Barbadensis Leaf Juice, Tocopherol, Sodium Hyaluronate, Magnesium Sulfate, Carica Papaya (Papaya) Fruit Extract, Vaccinium Macrocarpon (Cranberry) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Olea Europaea (Olive) Fruit Oil, Rubus Idaeus (Raspberry) Seed Oil, Hydrogenated Castor Oil, Caprylhydroxamic Acid, Triethoxycaprylylsilane, Glyceryl Caprylate.
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 sunburns 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.Thinkbaby Clear Zinc SPF 30 Zinc Oxide ZINC OXIDE ZINC OXIDE WATER MEDIUM-CHAIN TRIGLYCERIDES POLYGLYCERYL-4 ISOSTEARATE GLYCERIN GLYCERYL ABIETATE HEXYL LAURATE CETYL DIMETHICONE 150 SORBITAN SESQUIOLEATE ALOE VERA LEAF .ALPHA.-TOCOPHEROL HYALURONATE SODIUM BISPYRITHIONE MAGSULFEX ANHYDROUS PAPAYA CRANBERRY SEED OIL SUNFLOWER OIL JOJOBA OIL OLIVE OIL RASPBERRY SEED OIL HYDROGENATED CASTOR OIL CAPRYLHYDROXAMIC ACID TRIETHOXYCAPRYLYLSILANE GLYCERYL MONOCAPRYLATE
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.PRINCIPAL DISPLAY PANEL - 89 ml Tube Label thinkbaby 80 min water resistant dermatologist recommended CLEAR ZINC OXIDE SUNSCREEN 30 SPF broad spectrum UVA/UVB 100% mineral blends in quickly fragrance-free • EWG VERIFIED • FOR YOUR HEALTH • EWG.ORG 3 fl oz • 89 ml PRINCIPAL DISPLAY PANEL - 89 ml Tube Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Dist.by: Think Operations, LLC Simi Valley, CA 93065 USA
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin.
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.For Questions 877.446.1616
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if rash occurs.
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect this product 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. 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