Active Ingredients
Avobenzone 3.0%, Octinoxate 7.5%.
Moisturizer
FDA Label NDC 61354-032
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oxygen Development, Llc for the product Moisturizer (NDC 61354-032). 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, do not use, when using this product, stop use, 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.
Do Not Use
Do Not Use on damaged or broken skin.
When Using This Product
When using this product keep out of eyes. Rinse with water to remove.
Stop Use
Stop use and ask a doctor if rash occurs.
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Posion Contorl Center right away.
Directions
- For suncreen use:
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating.
- Reapply 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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
- Children under 6 months of age: Ask a doctor.
Other Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Water, diisopropyl sebacate, butylene gycol, cyclopentasiloxane, glyceryl stearate, stearic acid, cetyl phosphate, cetearyl alcohol, sh-oligopeptide-1, phenoxyethanol, sodium PCA, polysorbate 60, aminomethyl propanol, citrus aurantium dulcis (orange) fruit extract, allantoin, methylparaben, carbomer, bisabolol, propylparaben, tocopheryl acetate, disodium EDTA, laminaria saccharina extract, glycolipids, sodium hyaluronate.
Primary Package
61354-032-01_aw (Art 12616139)
Secondary Package
60ml, 61354-032-01
* Please review the disclaimer below.
