Label: DR.ALTHEA DOUBLE SERUM BALM FOUNDATION 23- octinoxate, octisalate, titanium dioxide, homosalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70905-0019-1, 70905-0019-2 - Packager: Dr.Althea Co.,Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 8, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
- KEEP OUT OF REACH OF CHILDREN
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR.ALTHEA DOUBLE SERUM BALM FOUNDATION 23
octinoxate, octisalate, titanium dioxide, homosalate creamProduct 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)
