Active Ingredients
Homosalate 7.5%, Octisalate 5%, Octocrylene 5%, Avobenzone 3%
Vacation World
FDA Label NDC 80641-005
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 World (NDC 80641-005). 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 active ingredients, purpose, uses, warnings, otc - do not use, otc - stop use, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- Contents under pressure. Do not puncture or incinerate can.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - When Using
When using this product
- Keep out fo eyes. Rinse with water to remove.
- Do not store at temperatures above 120 F.
Use only as directed. intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children. In case of ingestiion, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally 15 minutes before sun exposure. Dispense a ping pong ball size amount and apply to a single area (arm,leg,chest,or back). Repeat up to 4 times (roughly a tennis ball size amount) for a whole body application.
- Do not spray product directly on face. Spray onto hands and rub onto face.
- 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
- Chidlren under 6 months of age: ask a physician
Inactive Ingredients
Aloe Barbadensis (Aloe Vera) Leaf Juice, Aminomethyl Propanol, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexylglycerin, Fragrance, Glycerin, Microcrystalline Cellulose, Musa Sapientum (Banana) Fruit Extract, Niacinamide (Vitamin B3), VP/Hexadecene Copolymer, Phenoxyethanol, Polymethylsilsesquioxane, Polysorbate 20, Sodium Hyaluronate, Stearic Acid, Tapioca Starch, Tetrafluoropropene, Tetrasodium Glutamate Diacetate , Tocopheryl Acetate (Vitamin E), Water
Other Information
- Protect this product from excessive heat and direct sun
Vacation Classic Whip Broad Spectrum Spf 30 Sunscreen Mousse
Principal Display Label (Vacation)
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