DR.ALTHEA DOUBLE SERUM BALM FOUNDATION 23- octinoxate, octisalate, titanium dioxide, homosalate cream

Dr.Althea Double Serum Balm Foundation 23 by

Drug Labeling and Warnings

Dr.Althea Double Serum Balm Foundation 23 by is a Otc medication manufactured, distributed, or labeled by Dr.Althea Co.,Ltd, Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate 7.00%

Octisalate 4.80%

Titanium Dioxide 4.56%

Homosalate 2.50%

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.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.ALTHEA DOUBLE SERUM BALM FOUNDATION 23 
octinoxate, octisalate, titanium dioxide, homosalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70905-0019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.56 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2.5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
NIACINAMIDE (UNII: 25X51I8RD4)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
CERESIN (UNII: Q1LS2UJO3A)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
GLYCERETH-26 (UNII: NNE56F2N14)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE (UNII: 92RU3N3Y1O)
SQUALANE (UNII: GW89575KF9)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
HEXADECENE (MIXED ISOMERS) (UNII: 38H8547VP0)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70905-0019-2	2 in 1 CARTON	12/08/2021
1	NDC: 70905-0019-1	12 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/08/2021

Labeler - Dr.Althea Co.,Ltd (689694436)

Registrant - Dr.Althea Co.,Ltd (689694436)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080987545	manufacture(70905-0019)