Label: AEGIS DAILY FACIAL SPF 25- avobenzone, homosalate, octinoxate, octisalate, and octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 71690-201-01, 71690-201-50 - Packager: JNTLee Inc. dba Panacea
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 31, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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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
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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.
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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
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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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
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INGREDIENTS AND APPEARANCE
AEGIS DAILY FACIAL SPF 25
avobenzone, homosalate, octinoxate, octisalate, and octocrylene lotionProduct 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)
