AEGIS DAILY FACIAL SPF 25- avobenzone, homosalate, octinoxate, octisalate, and octocrylene lotion

Aegis Daily Facial by

Drug Labeling and Warnings

Aegis Daily Facial by is a Otc medication manufactured, distributed, or labeled by JNTLee Inc. dba Panacea, Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients

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

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

• apply liberally and evenly 15 minutes before sun exposure.
• reapply at least every 2 hours.
• use a water resistant sunscreen if swimming or sweating:
  • immediately after towel drying
  • at least every 2 hours.
• children under 6 months of age: Ask a doctor.
• 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 value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.

Other information

• protect the product in this container from excessive heat and direct sun

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

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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.

INGREDIENTS AND APPEARANCE

AEGIS DAILY FACIAL   SPF 25
avobenzone, homosalate, octinoxate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71690-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	68 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71690-201-01	1 in 1 CARTON	10/20/2017
1	NDC: 71690-201-50	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	10/20/2017

Labeler - JNTLee Inc. dba Panacea (080505573)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	MANUFACTURE(71690-201) , LABEL(71690-201) , PACK(71690-201)