FDA.reportPublic FDA data

Zermat Skin SPF 50 Broad Spectrum

Manufacturer
Zermat Internacional S.A. de C.V.
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:23:03

Label at a glance#

ProductZermat Skin SPF 50 Broad Spectrum
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE
Label structure6 sections

Indications and uses

Helps prevent sunburn, If used as directed with other sun protection measure (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15-minutes before sun exposure. Reapply: At least, every two-hours. Immediately after swimming, sweating or towel drying. Limit time in the sun, especially between 10am and 2pm. Wear long sleeve shirts, pants, hats and sunglasses. For children under 6 months, consult a physician. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use s...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Avobenzone..........3.00%

Homosalate..........10.00%

Octinoxate............7.50%

Octisalate..............5.00%

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn,
  • If used as directed with other sun protection measure (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes.
  • Rinse with water to remove.

Stop use and consult physician

OTC - STOP USE SECTION

If irritation

  • or rash develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical attention or contact poison control center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15-minutes before sun exposure. Reapply:
  • At least, every two-hours.
  • Immediately after swimming, sweating or towel drying.
  • Limit time in the sun, especially between 10am and 2pm.
  • Wear long sleeve shirts, pants, hats and sunglasses.
  • For children under 6 months, consult a physician.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: Sun Protection Measures:

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Camellia Sinensis (Green Tea) Leaf Extract, Cetearyl Alcohol, Cetearyl Olivate, Cocamidopropyl Betaine, Cucumis Sativus (Cucumber) Fruit Extract, Cyclotetrasiloxane, Cyclopentasiloxane, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glyceryl Stearate SE, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Laureth-7, Mangifera Indica (Mango) Seed Butter, Parfum (Fragrance), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Punica Granatum (Pomegranate) Extract, Soluble Collagen, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E), Zemea Propanediol.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15828-737-012021-08-31C16284748780-1ba0f9c33-376e-a910-e053-dadaa90a0b85Zermat Skin SPF 50 Broad Spectrum
15828-737-012021-01-29C16284748780-1ba0f9c33-376e-a910-e053-dadaa90a0b85Zermat Skin SPF 50 Broad Spectrum

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15828-73715828-737-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
SHEA BUTTERK49155WL9YIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL OLIVATE58B69Q84JOIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
CUCUMBERYY7C30VXJTIACT
CYCLOMETHICONE 4CZ227117JEIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
SUNFLOWER OIL3W1JG795YIIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LAURETH-7Z95S6G8201IACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
PUNICA GRANATUM ROOT BARKCLV24I3T1DIACT
SORBITAN OLIVATEMDL271E3GRIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
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
31debbb3-c91a-c10d-e063-6294a90a01226d74028a-550d-4ddd-a7ff-9f7cf96162e82025-04-03WarningsExact identifier
spl set id: 6d74028a-550d-4ddd-a7ff-9f7cf96162e8

Reported adverse events (FAERS/openFDA)#

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