Body oil 3 mg/100mL
Body oil · OIL · Guangzhou Yanxi Biotechnology Co., Ltd
This is an over-the-counter oil product applied to the skin at a concentration of 3 mg per 100 mL. Specific uses and benefits depend on the active ingredients in the formulation.
Key Facts
- Brand Name
- Body oil
- Generic Name
- Body oil
- NDC Code (Product)
84025-318- Manufacturer
- Guangzhou Yanxi Biotechnology Co., Ltd
- Strength
- 3 mg/100mL
- Dosage Form
- OIL
- Route
- CUTANEOUS
- Marketing Status
- Application #
- M016
- Marketing Start
- 01/07/2025
Recall History
Hill Dermaceuticals, Inc.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Hill Dermaceuticals, Inc.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Amneal Pharmaceuticals of New York, LLC
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Hill Dermaceuticals, Inc.
Subpotent; fluocinolone acetonide
Hill Dermaceuticals, Inc.
Subpotent; 12 month stability timepoint
Hill Dermaceuticals, Inc.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Hill Dermaceuticals, Inc.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Lyne Laboratories, Inc.
Subpotent Drug
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses. Helps prevent sunburn. higher SPF gives more sunburn protection retains SPF after 80 minutes of swimming or sweating If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin agingcaused by the sun.
Dosage & Administration
Directions Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. 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 increase your risk of skin cancer and early skin aging. To decrease this 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.-2p.m. Wear long-sleeved shirts, pants,hats,and sunglasses.
Warnings
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 or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use
Frequently Asked Questions
What is Body oil used for?
This is an over-the-counter oil product applied to the skin at a concentration of 3 mg per 100 mL. Specific uses and benefits depend on the active ingredients in the formulation.
Is Body oil a controlled substance?
Body oil is not classified as a controlled substance by the DEA.
What is the generic name for Body oil?
The generic name for Body oil is Body oil. There are no other listed brand versions of Body oil.
What is the NDC code for Body oil 3 mg/100mL?
The NDC (National Drug Code) for Body oil 3 mg/100mL is 84025-318, listed by Guangzhou Yanxi Biotechnology Co., Ltd.
Other Body oil Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)