Label: BE THE SKIN NATURAL BASE SUN- octinoxate, titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72802-001-01, 72802-001-02 - Packager: BETHESKIN 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 February 13, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Magnolia Liliflora Bud Extract, Cyclopentasiloxane, Water, Butylene Glycol, C12-15 Alkyl Benzoate, Isoamyl p-Methoxycinnamate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Disteardimonium Hectorite, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Glyceryl Behenate/Eicosadioate, Sodium Chloride, Triethoxycaprylylsilane, Mica, Methyl Methacrylate Crosspolymer, Cyclomethicone, Hydrogen Dimethicone, Hydrated Silica, Aluminum Hydroxide, Propylene Glycol Isostearate, Aluminum Stearate, Polyhydroxystearic Acid, Alumina, Scutellaria Baicalensis Root Extract, Paeonia Suffruticosa Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Laurus Nobilis Leaf Extract, Artemisia Umbelliformis Extract, Buddleja Davidii Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract, Aloe Barbadensis Leaf Extract, Honey Extract, Royal Jelly Extract, Tocopheryl Acetate, Stearyl Glycyrrhetinate, Disodium EDTA, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Fragrance
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BE THE SKIN NATURAL BASE SUN
octinoxate, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72802-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.07 g in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.053 g in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.039 g in 1 g Inactive Ingredients Ingredient Name Strength MAGNOLIA LILIIFLORA WHOLE (UNII: GDO2997SZZ) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BEMOTRIZINOL (UNII: PWZ1720CBH) AMILOXATE (UNII: 376KTP06K8) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP) CYCLOMETHICONE (UNII: NMQ347994Z) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM STEARATE (UNII: U6XF9NP8HM) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) HYDRATED SILICA (UNII: Y6O7T4G8P9) ROYAL JELLY (UNII: L497I37F0C) MICA (UNII: V8A1AW0880) STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72802-001-02 1 in 1 CARTON 02/12/2019 1 NDC:72802-001-01 50 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 02/12/2019 Labeler - BETHESKIN Co.,Ltd (688284035) Registrant - BETHESKIN Co.,Ltd (688284035) Establishment Name Address ID/FEI Business Operations Liebecos Co., Ltd 689156029 manufacture(72802-001)
