EPL DAILY SUN BLOCK- octinoxate, octisalate, zinc oxide, titanium dioxide cream 
Oracle Cosmetic 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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Drug Facts

Octinoxate 7.50%
Octisalate 5.00%

Zinc Oxide 4.90%
Titanium Dioxide 4.15%

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, 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

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

image description

EPL DAILY SUN BLOCK 
octinoxate, octisalate, zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71883-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION49 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE41.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71883-002-021 in 1 CARTON03/21/2018
1NDC:71883-002-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/21/201806/10/2021
Labeler - Oracle Cosmetic Co., Ltd. (688258270)

Revised: 6/2021
 
Oracle Cosmetic Co., Ltd.