CELEBEAU STAR SECRET CUSHION 02 VIOLET STAR- octinoxate, octisalate, zinc oxide, titanium dioxide cream 
SD BIOTECHNOLOGIES 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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Titanium Dioxide 8.300%

Octinoxate 7.000%

Octisalate 3.000%

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, Cyclopentasiloxane, Caprylyl Methicone, Cyclohexasiloxane, Butylene Glycol, Isoamyl p-Methoxycinnamate, Titanium Dioxide, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Diphenylsiloxy Phenyl Trimethicone, Alcohol Denat., Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, C12-15 Alkyl Benzoate, Sodium Chloride, Iron Oxides (CI 77492), Dimethicone, Trimethylsiloxysilicate, Sorbitan Sesquioleate, Isoamyl Laurate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Beeswax, Disteardimonium Hectorite, Polypropylsilsesquioxane, Iron Oxides (CI 77491), Mica (CI 77019), Dimethicone/Vinyl Dimethicone Crosspolymer, Isododecane, Alumina Ultramarines (CI 77007), Chlorphenesin, Trihydroxystearin, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Dipropylene, Glycol, 1,2-Hexanediol, Hydroxyacetophenone, Iron Oxides (CI 77499), Squalane, Tocopheryl Acetate, Propylene, Carbonate, Fragrance(Parfum), Triethoxycaprylylsilane, Adenosine, Disodium EDTA, Silica, Tin Oxide (CI 77861), Sophora Angustifolia Root Extract, Citrus Junos Fruit Extract, Eucalyptus Globulus Leaf Extract, Citrus Paradisi (Grapefruit) Seed Extract, Eugenia Caryophyllus (Clove) Flower Extract, Diamond powder, Lavandula Angustifolia (Lavender) Extract, Opuntia Ficus-Indica Extract, Sodium Hyaluronate, Vitis Vinifera (Grape) Fruit Extract, Tocopherol, Hydrolyzed Collagen

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

image description

CELEBEAU STAR SECRET CUSHION 02 VIOLET STAR 
octinoxate, octisalate, zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70142-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.245 g  in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.05 g  in 15 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.45 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
AMILOXATE (UNII: 376KTP06K8)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
Niacinamide (UNII: 25X51I8RD4)  
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
ALCOHOL (UNII: 3K9958V90M)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Dimethicone (UNII: 92RU3N3Y1O)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
ISOAMYL LAURATE (UNII: M1SLX00M3M)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
Isododecane (UNII: A8289P68Y2)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
SQUALANE (UNII: GW89575KF9)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70142-004-021 in 1 CARTON03/30/2018
1NDC:70142-004-0115 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 finalpart35203/30/2018
Labeler - SD BIOTECHNOLOGIES CO., LTD (688278067)
Registrant - SD BIOTECHNOLOGIES CO., LTD (688278067)
Establishment
NameAddressID/FEIBusiness Operations
Cit Co., Ltd.690081646manufacture(70142-004)

Revised: 3/2018
Document Id: f112ec2c-2ed1-402b-b3d9-ea9afbf3ca11
Set id: 652f5f11-52c2-4c00-a52b-2087acb60a89
Version: 1
Effective Time: 20180328
 
SD BIOTECHNOLOGIES CO., LTD