MORPHE SPF 30 BROAD SPECTRUM SUNSETTER SETTING- octisalate, octocrylene, avobenzone, homosalate spray

Morphe SPF 30 Broad Spectrum Sunsetter Setting by

Drug Labeling and Warnings

Morphe SPF 30 Broad Spectrum Sunsetter Setting by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORPORATION, COSMAX USA. CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Avobenzone 2%

Homosalate 9%

Octisalate 4.5%

Octocrylene 2%

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 cause by the sun

Warnings

Warnings

For extenal use only

Flammable

Flammable: Keep away from fire and flame.

Do not useon damaged or broken skin

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

Stop use and ask a doctor ifrash occurs

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

DIRECTIONS

Directions

• Apply evenly 15 minutes before sun exposure
  • Reapply
  • Reapply at least every 2 hours, or as needed
• Use a water resistant sunscreen if swimming or sweating
  • 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, especially from 10 a.m. - 2p.m.

-wear long-sleeved shirts, pants, hats and sunglasses

Children under 6 months of age: Ask a doctor

OTHER INFORMATION

Other information

• Protect the product in this container from excessive heat and direct sun
• May stain or damage some fabrics.

INACTIVE INGREDIENT

Inactive ingredients: Alcohol Denat., Isododecane, Butyloctyl Salicylate, PVP, Fragrance, Benzyl Benzoate, Ethylcellulose, Sodium Acetate, Glycine Soja (Soybean) Oil, Polyglyceryl-3 Diisostearate, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Water, Glycerin, Cereus Grandiflorus (Cactus) Flower Extract, Potassium Sorbate, Phenoxyethanol, Citric Acid, Sodium Benzoate, Tropaeolum Majus Flower/Leaf/Steam Extract, Ethylhexylglycerin.

QUESTIONS or COMMENTS

Questions or comments?

1-8771-877-900-6700 Monday - Friday (9 a.m. - 5 p.m. EST)

PRINCIPAL DISPLAY PANEL

Primary Package(Inner)

PRINCIPAL DISPLAY PANEL

Outer Package

INGREDIENTS AND APPEARANCE

MORPHE SPF 30 BROAD SPECTRUM SUNSETTER SETTING 
octisalate, octocrylene, avobenzone, homosalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-151
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 mg  in 100 mg
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 mg  in 100 mg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 mg  in 100 mg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ISODODECANE (UNII: A8289P68Y2)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POVIDONE (UNII: FZ989GH94E)
FRAGRANCE 13576 (UNII: 5EM498GW35)
BENZYL BENZOATE (UNII: N863NB338G)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
SODIUM ACETATE (UNII: 4550K0SC9B)
SOYBEAN OIL (UNII: 241ATL177A)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
RICE GERM (UNII: 7N2B70SFEZ)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SELENICEREUS GRANDIFLORUS FLOWER (UNII: II877K4UNR)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TROPAEOLUM MAJUS FLOWERING TOP (UNII: RGT30824HY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-151-01	1 in 1 CARTON	06/01/2023
1		100 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/01/2023

Labeler - COSMAX USA, CORPORATION (010990210)

Registrant - COSMAX USA, CORPORATION (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA. CORPORATION		010990210	manufacture(68577-151)