Otc - Active Ingredient
Avobenzone (2.8%)
Homosalate (9.8%)
Octisalate (4.9%)
Octocrylene (9.5%)
Vacation Spf 30 Baby Oil
FDA Label NDC 80641-011
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 Baby Oil (NDC 80641-011). 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 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
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
Other Information
• Protect this product from excessive heat and direct sun.
* Please review the disclaimer below.
