BE THE SKIN NATURAL BASE SUN- octinoxate, titanium dioxide, zinc oxide cream 
BETHESKIN 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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72802_001

Octinoxate 7.00%
Titanium Dioxide 5.30%
Zinc Oxide 3.90%

Sunscreen

Helps prevent sunburn

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

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.

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

image description

BE THE SKIN NATURAL BASE SUN 
octinoxate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72802-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.053 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.039 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72802-001-021 in 1 CARTON02/12/2019
1NDC:72802-001-0150 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 finalpart35202/12/2019
Labeler - BETHESKIN Co.,Ltd (688284035)
Registrant - BETHESKIN Co.,Ltd (688284035)
Establishment
NameAddressID/FEIBusiness Operations
Liebecos Co., Ltd689156029manufacture(72802-001)

Revised: 2/2019
Document Id: 81c14d65-845d-4de8-e053-2991aa0ab08e
Set id: 39ff9fdb-6faa-4275-ab74-b2b69206e61a
Version: 1
Effective Time: 20190213
 
BETHESKIN Co.,Ltd