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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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70905-0019_Dr.Althea Double Serum Balm Foundation 23

Octinoxate 7.00%

Octisalate 4.80%

Titanium Dioxide 4.56%

Homosalate 2.50%

Sunscreen

Helps prevent sunburn

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

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

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)

Protect the product in the container from excessive heat and direct sun

image description

DR.ALTHEA DOUBLE SERUM BALM FOUNDATION 23 
octinoxate, octisalate, titanium dioxide, homosalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70905-0019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.56 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70905-0019-22 in 1 CARTON12/08/2021
1NDC:70905-0019-112 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/08/2021
Labeler - Dr.Althea Co.,Ltd (689694436)
Registrant - Dr.Althea Co.,Ltd (689694436)
Establishment
NameAddressID/FEIBusiness Operations
Englewood Lab, Inc.080987545manufacture(70905-0019)

Revised: 12/2021
Document Id: d2ab2530-ac48-b1f1-e053-2995a90aad8b
Set id: 9de85eac-08ba-42c6-9508-92c101d79c12
Version: 1
Effective Time: 20211208
 
Dr.Althea Co.,Ltd