ASYSTEM DAILY DEFENSE MOISTURIZER SPF30- homosalate lotion

ASYSTEM Daily Defense Moisturizer SPF30 by

Drug Labeling and Warnings

ASYSTEM Daily Defense Moisturizer SPF30 by is a Otc medication manufactured, distributed, or labeled by Cosco International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASYSTEM DAILY DEFENSE MOISTURIZER SPF30 
homosalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52261-4900
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.08 kg  in 1 kg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 kg  in 1 kg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.055 kg  in 1 kg
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52261-4900-0	1 in 1 CARTON	07/30/2019
1	NDC: 52261-4900-1	0.030 kg 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	07/30/2019

Labeler - Cosco International, Inc. (016433141)

Registrant - Cosco International, Inc. (016433141)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc.		016433141	manufacture(52261-4900) , label(52261-4900) , pack(52261-4900)