Active Ingredients
Homosalate 7.5 %
Octyl salicylate 4.5 %
Titanium dioxide 2.2 %
Zinc oxide 12.7 %
Dr.oracle Air Fit Defense Soothing Sunscreen Cream
FDA Label NDC 71883-050
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oracle Cosmetic Co., Ltd. for the product Dr.oracle Air Fit Defense Soothing Sunscreen (NDC 71883-050). 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 and ask a doctor if, 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
• on damaged skin 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
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ apply liberally 15 minutes before sun exposure.
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. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
■ children under 6 months of age: Ask a doctor
■ reapply at least every 2 hours
■ use a water-resistant sunscreen if swimming or sweating
Other Information
■ protect the product from excessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Inactive Ingredients
Water, Cyclopentasiloxane, Coco-Caprylate/Caprate, Dipropylene Glycol, Lauryl PEG-10 Tris(Trimethylsiloxy)Silylethyl Dimethicone, Glycerin, Niacinamide, Butyloctyl Salicylate, Methyl Methacrylate Crosspolymer, Dist- eardimonium Hectorite, Magnesium Sulfate, Vinyl Dimethicone/Methicone Silsesquioxane Cross- polymer, Dimethicone, 1,2-Hexanediol,Triethoxycaprylylsilane, Stearic Acid, Aluminum Hydroxide, Sorbitan Caprylate, Dimethicone/PEG- 10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Ethylhexylglycerin, Sodium Citrate, Tocopherol
* Please review the disclaimer below.
