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| Product NDC Code | 80641-011 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Vacation spf 30 baby oil |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | OIL | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Vacation 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.Avobenzone (2.8%) Homosalate (9.8%) Octisalate (4.9%) Octocrylene (9.5%)
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 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 the risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses • Children under 6 months of age: ask a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Jasminum Officinale (Jasmine) Extract, Methyl Dihydroabietate, Polyester-8, Rosa Canina (Rose) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Trimethylpentanediol/ Adipic Acid/Glycerin Crosspolymer
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.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Vacation SPF 30 Baby Oil Avobenzone, Homosalate, Octisalate, Octocrylene HOMOSALATE HOMOSALATE LEVOMENOL BUTYLOCTYL SALICYLATE ALKYL (C12-15) BENZOATE CALENDULA OFFICINALIS FLOWER TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) MATRICARIA RECUTITA FLOWERING TOP SUNFLOWER OIL JASMINUM OFFICINALE FLOWER OCTISALATE OCTISALATE MEDIUM-CHAIN TRIGLYCERIDES METHYL DIHYDROABIETATE POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) ROSA CANINA SEED OIL AVOBENZONE AVOBENZONE JOJOBA OIL TOCOPHEROL SAFFLOWER OIL ISOPROPYL MYRISTATE OCTOCRYLENE OCTOCRYLENE
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.1
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. In case of ingestion, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.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 • When using this produc t, 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