AEGIS DAILY FACIAL  SPF 25- avobenzone, homosalate, octinoxate, octisalate, and octocrylene lotion 
JNTLee Inc. dba Panacea

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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Aegis Daily Facial SPF
SPF 25

Drug Facts

Active ingredients

Avobenzone, 2.9%
Homosalate, 9.0%
Octinoxate, 6.8%
Octisalate, 4.5%
Octocrylene 5.0%

Purpose

Sunscreen

Uses

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 use and ask a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Alcohol, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Centella Asiatica Extract, Cetearyl Alcohol, Dimethicone, Dipropylene Glycol, Echium Plantagineum Seed Oil, Ethylhexylglycerin, Fragrance (Parfum), Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, 1,2- Hexanediol, Houttuynia Cordata Extract, Methyl Methacrylate Crosspolymer, Octyldodecanol, Phenoxyethanol, Polyacrylate Crosspolymer-6, Portulaca Oleracea Extract, Potassium Cetyl Phosphate, Propanediol, t-Butyl Alcohol, Tocopherol, Tromethamine, Water/Aqua/Eau, Xanthan Gum.

Questions or comments?

Call toll free 1-888-347-4575

Monday – Friday 9 a.m. – 5 p.m. PST ; www.thepanacea.com

Dist. by Panacea
Los Angeles, CA 90046

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

PANACEA
SKINCARE

THE AEGIS

Daily Facial SPF

Broad Spectrum
SPF 25

50 mL / 1.69 fl. oz.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
AEGIS DAILY FACIAL   SPF 25
avobenzone, homosalate, octinoxate, octisalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71690-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE68 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PURSLANE (UNII: M6S840WXG5)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PROPANEDIOL (UNII: 5965N8W85T)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TROMETHAMINE (UNII: 023C2WHX2V)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71690-201-011 in 1 CARTON10/20/2017
1NDC:71690-201-5050 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35210/20/2017
Labeler - JNTLee Inc. dba Panacea (080505573)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611MANUFACTURE(71690-201) , LABEL(71690-201) , PACK(71690-201)

Revised: 8/2017
Document Id: 3fa98c98-03ae-4c00-beb7-3b0b49f46a78
Set id: 4f09bc31-96d9-4aee-bc87-fcaa86af70dc
Version: 1
Effective Time: 20170831
 
JNTLee Inc. dba Panacea