FDA.reportPublic FDA data

Aegis Daily Facial

Manufacturer
JNTLee Inc. dba Panacea | Kolmar Korea Co., Ltd.
Effective date
2017-08-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:44

Label at a glance#

ProductAegis Daily Facial SPF 25
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
Label structure11 sections

Indications and 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

Dosage and administration

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...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call toll free 1-888-347-4575

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

SPL UNCLASSIFIED SECTION

Dist. by Panacea
Los Angeles, CA 90046

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PANACEA
SKINCARE

THE AEGIS

Daily Facial SPF

Broad Spectrum
SPF 25

50 mL / 1.69 fl. oz.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71690-201-012022-01-28C16284748780-1d6a99b39-829f-a426-e053-dadaa90af4c2Aegis Daily Facial SPF SPF 25

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71690-201-01Aegis Daily Facial SPF 251 in 1 CARTONLOTION11
71690-201-50Aegis Daily Facial SPF 2550 mL in 1 BOTTLE, PUMPLOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71690-201AEGIS DAILY FACIAL SPF 25 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENE) LOTION [JNTLEE INC. DBA PANACEA]1Legacy NDC, 2 package rows20171020_4f09bc31-96d9-4aee-bc87-fcaa86af70dc.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71690-20171690-201-50, 71690-201-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ALCOHOL3K9958V90MIACT
CARDIOSPERMUM HALICACABUM FLOWERING TOPMZP2508BRRIACT
CENTELLA ASIATICA7M867G6T1UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
DIPROPYLENE GLYCOLE107L85C40IACT
ECHIUM PLANTAGINEUM SEED OILPIB7XBU8XWIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SUNFLOWER OIL3W1JG795YIIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
HOUTTUYNIA CORDATA FLOWERING TOPRH041UUZ22IACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
OCTYLDODECANOL461N1O614YIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PURSLANEM6S840WXG5IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
PROPANEDIOL5965N8W85TIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
TOCOPHEROLR0ZB2556P8IACT
TROMETHAMINE023C2WHX2VIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3fa98c98-03ae-4c00-beb7-3b0b49f46a784f09bc31-96d9-4aee-bc87-fcaa86af70dc2017-08-31WarningsExact identifier
spl id: 3fa98c98-03ae-4c00-beb7-3b0b49f46a78
spl set id: 4f09bc31-96d9-4aee-bc87-fcaa86af70dc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.