Otc - Active Ingredient
Zinc Oxide 15.5%
Vacation Spf 30 Mineral Lotion
FDA Label NDC 80641-009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vacation Inc. for the product Vacation Spf 30 Mineral (NDC 80641-009). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredient, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
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
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away.
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
Inactive Ingredient
Allantoin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Alcohol , Cucumis Sativus (Cucumber) Fruit Extract, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Glycerin, Glyceryl Behenate/Eicosadioate, Isododecane, Isopropyl Myristate, Magnesium Sulfate, Methyl Dihydroabietate, Niacinamide (Vitamin B3), Polyglyceryl-3 Oleate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Propanediol, Sodium Gluconate, Tocopherol (Vitamin E), Water, Xanthan Gum
Other Information
• Protect this product from excessive heat and direct sun
* Please review the disclaimer below.
