CELEBEAU STAR SECRET CUSHION 02 VIOLET STAR- octinoxate, octisalate, zinc oxide, titanium dioxide cream

Celebeau Star Secret Cushion 02 Violet Star by

Drug Labeling and Warnings

Celebeau Star Secret Cushion 02 Violet Star by is a Otc medication manufactured, distributed, or labeled by SD BIOTECHNOLOGIES CO., LTD, Cit Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 8.300%

Octinoxate 7.000%

Octisalate 3.000%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

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

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 CHILDREN

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

INACTIVE INGREDIENT

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

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CELEBEAU STAR SECRET CUSHION 02 VIOLET STAR 
octinoxate, octisalate, zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70142-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.245 g  in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.05 g  in 15 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.45 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70142-004-02	1 in 1 CARTON	03/30/2018
1	NDC: 70142-004-01	15 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	03/30/2018

Labeler - SD BIOTECHNOLOGIES CO., LTD (688278067)

Registrant - SD BIOTECHNOLOGIES CO., LTD (688278067)

Establishment
Name	Address	ID/FEI	Business Operations
Cit Co., Ltd.		690081646	manufacture(70142-004)