Label: ASYSTEM DAILY DEFENSE MOISTURIZER SPF30- homosalate lotion
- NDC Code(s): 52261-4900-0, 52261-4900-1, 52261-4900-2
- Packager: Cosco International, Inc.
- 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 February 14, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Uses
- Warnings
-
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
- Questions?
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ASYSTEM DAILY DEFENSE MOISTURIZER SPF30
homosalate lotionProduct 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 2 NDC:52261-4900-2 0.002 kg in 1 PACKET; Type 0: Not a Combination Product 07/30/2019 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)
