ASYSTEM DAILY DEFENSE MOISTURIZER SPF30- homosalate lotion 
Cosco International, Inc.

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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ASYSTEM Daily Defense Moisturizer + SPF 30

Drug Facts

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

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

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

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

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

When using the product keep out of eyes.

Rinse with water to remove.

Seek out a doctor if rash occurs.

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

Directions

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

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

Protect this product from excessive heat and direct sun.

Questions?

info@asystem.com

30ml label

30ml carton

sachet label

ASYSTEM DAILY DEFENSE MOISTURIZER SPF30 
homosalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-4900
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.08 kg  in 1 kg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 kg  in 1 kg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.055 kg  in 1 kg
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 kg  in 1 kg
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALMOND OIL (UNII: 66YXD4DKO9)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
ISODODECANE (UNII: A8289P68Y2)  
WATER (UNII: 059QF0KO0R)  
WATERMELON (UNII: 231473QB6R)  
APPLE (UNII: B423VGH5S9)  
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
ISOMALT (UNII: S870P55O2W)  
SAPONARIA OFFICINALIS LEAF (UNII: 3988313MM7)  
KIWI FRUIT (UNII: 71ES77LGJC)  
SWERTIA CHIRAYITA WHOLE (UNII: 98BFC3JT53)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52261-4900-01 in 1 CARTON07/30/2019
1NDC:52261-4900-10.030 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:52261-4900-20.002 kg in 1 PACKET; Type 0: Not a Combination Product07/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/30/2019
Labeler - Cosco International, Inc. (016433141)
Registrant - Cosco International, Inc. (016433141)
Establishment
NameAddressID/FEIBusiness Operations
Cosco International, Inc.016433141manufacture(52261-4900) , label(52261-4900) , pack(52261-4900)

Revised: 2/2022
Document Id: e67a890c-373e-43a7-8750-3ab5345ce963
Set id: b0b3da3b-4fbf-4460-96c2-037b6aaf20c1
Version: 3
Effective Time: 20220214
 
Cosco International, Inc.