FDA.reportPublic FDA data

Morphe SPF30 Broad Spectrum Sunsetter Setting Spray

Manufacturer
COSMAX USA, CORPORATION | COSMAX USA. CORPORATION
Effective date
2024-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:55

Label at a glance#

ProductMorphe SPF 30 Broad Spectrum Sunsetter Setting
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Label structure10 sections

Indications and 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

Dosage and administration

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: - l...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Avobenzone 2%

Homosalate 9%

Octisalate 4.5%

Octocrylene 2%

OTC - PURPOSE SECTION

Purpose

Sunscreen

USES

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

For extenal use only

Flammable

WARNINGS SECTION

Flammable: Keep away from fire and flame.

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor ifrash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

Questions or comments?

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottlePrimary Package(Inner)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package

Outer packageOuter package

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-151-01Morphe SPF 30 Broad Spectrum Sunsetter Setting100 mg in 1 BOTTLE, SPRAYSPRAY1002
68577-151-01Morphe SPF 30 Broad Spectrum Sunsetter Setting1 in 1 CARTONSPRAY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-151MORPHE SPF 30 BROAD SPECTRUM SUNSETTER SETTING (OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE) SPRAY [COSMAX USA, CORPORATION]2Current NDC, 2 package rows20241228_0d34406f-9dd0-3909-e063-6394a90ab9f9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-15168577-151-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
ALCOHOL3K9958V90MIACT
ISODODECANEA8289P68Y2IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
POVIDONEFZ989GH94EIACT
FRAGRANCE 135765EM498GW35IACT
BENZYL BENZOATEN863NB338GIACT
ETHYLCELLULOSES7Z8S9VYZ4BIACT
SODIUM ACETATE4550K0SC9BIACT
SOYBEAN OIL241ATL177AIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
RICE GERM7N2B70SFEZIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SELENICEREUS GRANDIFLORUS FLOWERII877K4UNRIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM BENZOATEOJ245FE5EUIACT
TROPAEOLUM MAJUS FLOWERING TOPRGT30824HYIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Morphe SPF 30 Broad Spectrum Sunsetter SettingOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d34406f-9dd0-3909-e063-6394a90ab9f92024-12-26WarningsExact identifier
ndc (package): 68577-151-01
ndc (product): 68577-151
ndc11 (package): 68577015101
spl id: 2a268315-4ad3-5f77-e063-6294a90ab671
spl set id: 0d34406f-9dd0-3909-e063-6394a90ab9f9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.