EPL DAILY SUN BLOCK- octinoxate, octisalate, zinc oxide, titanium dioxide cream

EPL DAILY SUN BLOCK by

Drug Labeling and Warnings

EPL DAILY SUN BLOCK by is a Otc medication manufactured, distributed, or labeled by Oracle Cosmetic Co., Ltd., EYESOME. Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate 7.50%
Octisalate 5.00%

Zinc Oxide 4.90%
Titanium Dioxide 4.15%

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, Propylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Isoamyl p-Methoxycinnamate, Hydrogenated Polydecene, Betaine, Ethylhexyl Isononanoate, Polyglyceryl-4 Isostearate, Magnesium Sulfate, Disteardimonium Hectorite, Aluminum Hydroxide, Stearic Acid, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, 1,2-Hexanediol, Tocopheryl Acetate, Triethoxycaprylylsilane, Portulaca Oleracea Extract, Aloe Barbadensis Leaf Juice, Piper Methysticum Leaf/Root/Stem Extract, PEG-8, PEG-8/SMDI Copolymer, Echium Plantagineum Seed Oil, Octyldodecanol, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed OilUnsaponifiables, Copper Tripeptide-1, Fragrance

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EPL DAILY SUN BLOCK 
octinoxate, octisalate, zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71883-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	49 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	41.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
AMILOXATE (UNII: 376KTP06K8)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
BETAINE (UNII: 3SCV180C9W)
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
Stearic Acid (UNII: 4ELV7Z65AP)
Phenoxyethanol (UNII: HIE492ZZ3T)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
1,2-Hexanediol (UNII: TR046Y3K1G)
Triethoxycaprylylsilane (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PURSLANE (UNII: M6S840WXG5)
PEG-8/SMDI COPOLYMER (UNII: CCX72L6NY6)
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)
PREZATIDE COPPER (UNII: 6BJQ43T1I9)
OCTYLDODECANOL (UNII: 461N1O614Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71883-002-02	1 in 1 CARTON	03/21/2018
1	NDC: 71883-002-01	50 mL 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	03/21/2018

Labeler - Oracle Cosmetic Co., Ltd. (688258270)

Registrant - Oracle Cosmetic Co., Ltd. (688258270)

Establishment
Name	Address	ID/FEI	Business Operations
EYESOME. Co.,Ltd.		557795360	manufacture(71883-002)