Dr.Althea Double Serum Balm Foundation 23

Manufacturer
Dr.Althea Co.,Ltd | Englewood Lab, Inc.
Effective date
2021-12-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:45:30

Label at a glance#

ProductDr.Althea Double Serum Balm Foundation 23
Active ingredientTITANIUM DIOXIDE, HOMOSALATE, OCTINOXATE, OCTISALATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.00%

Octisalate 4.80%

Titanium Dioxide 4.56%

Homosalate 2.50%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Helps prevent sunburn

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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 SECTION

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70905-0019-22023-01-30C16284748780-1f386c64a-4700-0266-e053-dadaa90a7c1a70905-0019_Dr.Althea Double Serum Balm Foundation 23

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70905-0019-1Dr.Althea Double Serum Balm Foundation 2312 g in 1 CONTAINERCREAM121
70905-0019-2Dr.Althea Double Serum Balm Foundation 232 in 1 CARTONCREAM21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70905-0019DR.ALTHEA DOUBLE SERUM BALM FOUNDATION 23 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, HOMOSALATE) CREAM [DR.ALTHEA CO.,LTD]1Legacy NDC, 2 package rows20211209_9de85eac-08ba-42c6-9508-92c101d79c12.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70905-001970905-0019-1, 70905-0019-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d2ab2530-ac48-b1f1-e053-2995a90aad8b9de85eac-08ba-42c6-9508-92c101d79c122021-12-08WarningsExact identifier
spl id: d2ab2530-ac48-b1f1-e053-2995a90aad8b
spl set id: 9de85eac-08ba-42c6-9508-92c101d79c12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.