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Vacation spf 30 chardonnay oil - Medication Information

Product NDC Code 80641-008
Drug Name

Vacation spf 30 chardonnay oil

Type Brand
Active Ingredients
Avobenzone 2.9 g/100ml
Homosalate 9.8 g/100ml
Octisalate 4.9 g/100ml
Octocrylene 9.5 g/100ml
Route TOPICAL
Dosage Form OIL
Application Number M020
Labeler Name Vacation Inc.
Packages
Package NDC Code Description
80641-008-01 100 ml in 1 bottle, plastic (80641-008-01)
80641-008-02 30 ml in 1 bottle, plastic (80641-008-02)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Avobenzone (2.9%) 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: • after 80 minutes of swimming or sweating • immediately after towel drying • 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 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, Butyrospermum Parkii (Shea) Oil, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Fragrance, Isopropyl Myristrate, Methyl Dihydroabietate, Passiflora Edulis (Passionfruit) Seed Oil, Polyester-8, Sclerocarya Birrea (Marula) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E),Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Vitis Vinifera (Chardonnay Grape) Seed Oil

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 Chardonnay Oil Avobenzone, Homosalate, Octisalate, Octocrylene HOMOSALATE HOMOSALATE LEVOMENOL BUTYLOCTYL SALICYLATE ALKYL (C12-15) BENZOATE TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) OCTISALATE OCTISALATE MEDIUM-CHAIN TRIGLYCERIDES METHYL DIHYDROABIETATE POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) AVOBENZONE AVOBENZONE JOJOBA OIL TOCOPHEROL ISOPROPYL MYRISTATE OCTOCRYLENE OCTOCRYLENE SHEANUT OIL PASSIFLORA EDULIS SEED OIL SCLEROCARYA BIRREA SEED OIL GRAPE SEED OIL

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