Otc - Active Ingredient
Octinoxate 7.00%
Octisalate 4.80%
Titanium Dioxide 4.56%
Homosalate 2.50%
Dr.althea Double Serum Balm Foundation 23
FDA Label NDC 70905-0019
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dr.althea Co.,ltd for the product Dr.althea Double Serum Balm Foundation 23 (NDC 70905-0019). 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, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
Helps prevent sunburn
Dosage & Administration
Apply liberally 15 minutes before sun exposure. Reapply at least every two 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months
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 using and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.
Inactive Ingredient
Water (Aqua), Dipropylene Glycol, Phenyl Trimethicone, Cyclopentasiloxane, C30-45 Alkyldimethylsilyl Polypropylsilsesquioxane, Niacinamide, Diisostearyl Malate, VP/Hexadecene Copolymer, Ceresin, Cyclohexasiloxane, Glycereth-26, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Sodium Chloride, Adansonia Digitata Seed Extract, Camellia Japonica Flower Extract, Hyaluronic Acid, Ceramide NP, Hexapeptide-9, Acetyl Hexapeptide-8, Tripeptide-1, Tripeptide-32, Chitosan, Hydrogenated Lecithin, Dimethicone, Methyl Methacrylate Crosspolymer, Squalane, Aluminum Hydroxide, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Glyceryl Caprylate, Stearic Acid, Dimethicone/PEG-10/15 Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Hexadecene, Triethoxycaprylylsilane, Disodium Stearoyl Glutamate, Adenosine, Glycerin, Caprylic/Capric Triglyceride, Tripropylene Glycol, Sodium Citrate, Butylene Glycol, Propylene Glycol, 1,2-Hexanediol, Ethylhexylglycerin, Tocopherol, Tocopheryl Acetate, Disodium EDTA, BHT, Phenoxyethanol, Fragrance (Parfum), Ultramarines, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)
Other Safety Information
Protect the product in the container from excessive heat and direct sun
* Please review the disclaimer below.
