FDA.reportPublic FDA data

ASYSTEM Daily Defense Moisturizer SPF30

Manufacturer
Cosco International, Inc.
Effective date
2022-02-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:48:15

Label at a glance#

ProductASYSTEM Daily Defense Moisturizer SPF30
Active ingredientHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE
Label structure10 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 15 minutes before sun exposure. Reapply at least every 2 hours, as well as after 40 minutes of sweating, immediately after towel drying. 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 least a broad spectrum SPF of 15 or higher and other sun protecting measures including: limiting tim...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient....................Purpose

Homosalate   8.00%..................Sunscreen

Octilsalate     5.00%..................Sunscreen

Octocrylene   5.50%..................Sunscreen

Avobenxone   3.00%..................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 broken or damaged skin.

OTC - WHEN USING SECTION

When using the product keep out of eyes.

Rinse with water to remove.

OTC - ASK DOCTOR SECTION

Seek out a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If product is swallowed, call a doctor or poison control center immediately.

Directions

INSTRUCTIONS FOR USE SECTION

Apply liberally 15 minutes before sun exposure.

Reapply at least every 2 hours, as well as after 40 minutes of sweating, immediately after towel drying.

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 least a broad spectrum SPF of 15 or higher and other sun protecting measures including: limiting time in the sun, especially from 10am-2pm, and wearing long-sleeved shirts, pants, hats and sunglasses.

For children under 8 months, ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), C12-15 Alkyl Benzoate, Glycerin, Diisostearyl Malate, Glyceryl Stearate Citrate, Stearic Acid, Glycol Distearate, Ethylhexylglycerin, Hexylene Glycol, Xanthan Gum, Prunus Amygdalus Dulcia (Sweet Almond) Oil, Actinidia Chinensis (Kiwi) Fruit Extract, Cyanidium Caldarium Extract, Saponaria Pumila Callus Culture Extract, Isomalt, Lecithin, Maltodextrin, Swertia Chirata Leaf Extract, Vitis Vinifera (Grape) Juice Extract, Glycerin, Citrus Vulgaris (Watermelon) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Lens Esculenta (Lentil) Fruit Extract, Sodium PCA, Sodium Lactate, Tocopheryl Acetate, Hydoxyethylcellulose, Eucalyptus Globulus Leaf Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil

Other Information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

Questions?

OTC - QUESTIONS SECTION

info@asystem.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30ml label30ml label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30ml carton30ml carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sachet labelsachet label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52261-4900-02025-01-30C16284748780-12cef2736-742f-d83d-e063-dadaa90ab31fASYSTEM Daily Defense Moisturizer + SPF 30
52261-4900-22025-01-30C16284748780-12cef2736-742f-d83d-e063-dadaa90ab31fASYSTEM Daily Defense Moisturizer + SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52261-4900-0ASYSTEM Daily Defense Moisturizer SPF301 in 1 CARTONLOTION13
52261-4900-1ASYSTEM Daily Defense Moisturizer SPF300.030 kg in 1 BOTTLE, PUMPLOTION0.0303
52261-4900-2ASYSTEM Daily Defense Moisturizer SPF300.002 kg in 1 PACKETLOTION0.0023

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52261-4900ASYSTEM DAILY DEFENSE MOISTURIZER SPF30 (HOMOSALATE) LOTION [COSCO INTERNATIONAL, INC.]3Legacy NDC, 3 package rows20220215_b0b3da3b-4fbf-4460-96c2-037b6aaf20c1.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52261-490052261-4900-1, 52261-4900-0, 52261-4900-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CITRUS AURANTIUM FRUIT OIL59JDQ5VT0TIACT
PHYMATOLITHON CALCAREUM6J1M3WA0ZKIACT
XANTHAN GUMTTV12P4NEEIACT
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%)X70SE62ZARIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
GLYCERINPDC6A3C0OXIACT
ALMOND OIL66YXD4DKO9IACT
STEARIC ACID4ELV7Z65APIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
ISODODECANEA8289P68Y2IACT
WATER059QF0KO0RIACT
WATERMELON231473QB6RIACT
APPLEB423VGH5S9IACT
LENS CULINARIS FRUITZYZ076G9JHIACT
SODIUM LACTATETU7HW0W0QTIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCOL DISTEARATE13W7MDN21WIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MALTODEXTRIN7CVR7L4A2DIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
ISOMALTS870P55O2WIACT
SAPONARIA OFFICINALIS LEAF3988313MM7IACT
KIWI FRUIT71ES77LGJCIACT
SWERTIA CHIRAYITA WHOLE98BFC3JT53IACT
LECITHIN, SOYBEAN1DI56QDM62IACT

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
e67a890c-373e-43a7-8750-3ab5345ce963b0b3da3b-4fbf-4460-96c2-037b6aaf20c12022-02-14WarningsExact identifier
spl id: e67a890c-373e-43a7-8750-3ab5345ce963
spl set id: b0b3da3b-4fbf-4460-96c2-037b6aaf20c1

Reported adverse events (FAERS/openFDA)#

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