MUSELY DAYCREAM SPF40- zinc oxide cream

MUSELY DAYCREAM SPF40 by

Drug Labeling and Warnings

MUSELY DAYCREAM SPF40 by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient:

Zinc Oxide 12.3%

PURPOSE

Purpose

Sunscreen

Uses

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

Warnings: For external use only

Do noy use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions: Appy liberally and evenly 15 minutes before sun exposure.

• Reapply
• after 80 minutes of sweating or activity in water
• immediately after towel drying
• at least every 2 hours
• 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, especuallt from 10 a.m. - 2p.m.
• Wear long sleeve shirts, pants, hats, and sunglasses
• Children under 6 months:ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients:Water, Isoamyl Laurate, Glycerin, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polyglyceryl-10 Stearate, Poly C10-30 Alkyl Acrylate, Polyhydroxystearic Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetearyl Olivate, Sorbitan Olivate, Hydroxyacetophenone, Phenoxyethanol, Polyglyceryl-10 Laurate, Microcrystalline Cellulose, Limonene, Rubus Idaeus (Raspberry) Seed Oil, Xanthan Gum, Glycine Soja (Soybean) Oil, Cellulose Gum, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Polyglyceryl-3 Diisostearate, Citrus Limon (Lemon) Peel Oil, Linalool, Citrus Aurantium Dulcis (Orange) Peel Oil, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Lavandula Angustifolia (Lavender) Oil, Propanediol, Ocimum Basilicum (Basil) Oil, Pelargonium Graveolens Flower Oil, Citral, Centella Asiatica Extract.

Other Information

Other information:

• Protect the product in this container from excessive heat and direct sun
• Avoid storing at extreme temperatures (below 40F and above 100F)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MUSELY DAYCREAM SPF40 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-198
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12.3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOAMYL LAURATE (UNII: M1SLX00M3M)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CITRUS AURANTIUM BERGAMIA (BERGAMOT) PEEL OIL (UNII: 39W1PKE3JI)
CELLULOSE GUM (UNII: K679OBS311)
CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL (UNII: AKN3KSD11B)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL (UNII: ZBP1YXW0H8)
OCIMUM BASILICUM (BASIL) OIL (UNII: Z129UMU8LE)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCINE SOJA (SOYBEAN) OIL (UNII: 241ATL177A)
GLYCERIN (UNII: PDC6A3C0OX)
RUBUS IDAEUS (RASPBERRY) SEED OIL (UNII: 9S8867952A)
RICE GERM (UNII: 7N2B70SFEZ)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
PROPANEDIOL (UNII: 5965N8W85T)
CITRAL (UNII: T7EU0O9VPP)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CITRUS LIMON (LEMON) PEEL OIL (UNII: I9GRO824LL)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-198-00	60 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2024

Labeler - COSMAX USA, CORPORATION (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA, CORPORATION		010990210	manufacture(68577-198)