FDA.reportPublic FDA data

ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50)

Manufacturer
ZITSTICKA, Inc
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:00:01

Label at a glance#

ProductZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50)
Active ingredientHOMOSALATE, OCTINOXATE, OCTISALATE, ZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn. Higher SPF gives more sunburn protection 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

Dosage and administration

• Apply liberally 15 minutes before sun exposure • Children under 6 months of age: ask a doctor. • Reapply at least every 2 hours • Reapply 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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other s...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 7.50% Octinoxate 7.50% Octisalate 5.00% Zinc Oxide 3.00%


Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection
  • 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 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 ask a doctor if:

OTC - STOP USE SECTION

Rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Directions:

DOSAGE & ADMINISTRATION SECTION

• Apply liberally 15 minutes before sun exposure • Children under 6 months of age: ask a doctor. • Reapply at least every 2 hours • Reapply 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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.






Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Teat) Extract, Caprylic/Capric Triglyceride, Carbomer, Citric Acid, Citrullus Lantus (Watermelon) Extract, Ceramide NG, Cetearyl Alcohol, Cetearyl Glucoside, Cocamidopropyl Betaine, Colloidal Oatmeal, Daucus Carota Sativa (Carrot) Extract, Dodecane, Ferulic Acid, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hyaluronic Acid, Hydrogenated Methyl Abietate, Hydropropyl Cyclodextrin, Leuconostoc/Radish Root Ferment Filtrate, Melaleuca Alternifolia (Tea Tree) Oil, Niacinamide, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Palmitoyl Tripeptide-38, Phenyl Trimethicone, Polysorbate-20, Terminalia Ferdinandiana (Kakadu Plum) Oil, Thymus Vulgaris (Thyme) Extract.

Other Information:

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun.

Questions?

OTC - QUESTIONS SECTION

+1 (424) 274 4500

Package Labeling:81746-183-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling:81746-183-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81746-183-00ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50)1 in 1 BOXLIQUID13
81746-183-00ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50)50 mL in 1 BOTTLE, DROPPERLIQUID503
81746-183-01ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50)1 in 1 BOXLIQUID13
81746-183-01ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50)30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81746-183ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50) (HOMOSALATE, OCTINOXATE, OCTISALATE, ZINC OXIDE) LIQUID [ZITSTICKA, INC]3Current NDC, Legacy NDC, 4 package rows20231112_32164318-7a7e-40b2-99da-8246c99fdbd3.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81746-18381746-183-00, 81746-183-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATERMELON231473QB6RIACT
CERAMIDE NGC04977SRJ5IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
OATMEAL8PI54V663YIACT
CARROTL56Z1JK48BIACT
DODECANE11A386X1QHIACT
FERULIC ACIDAVM951ZWSTIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
HYALURONIC ACIDS270N0TRQYIACT
HYDROGENATED METHYL ABIETATEA23O709X8OIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
NIACINAMIDE25X51I8RD4IACT
PALMITOYL TETRAPEPTIDE-7Q41S464P1RIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
PALMITOYL LYSYLDIOXYMETHIONYLLYSINET7A529FB8OIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
POLYSORBATE 207T1F30V5YHIACT
KAKADU PLUM0ZQ1D2FDLIIACT
THYMECW657OBU4NIACT
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50)HOMOSALATE, OCTINOXATE, OCTISALATE, ZINC OXIDEZITSTICKA, Inc32164318-7a7e-40b2-99da-8246c99fdbd32023-11-11WarningsExact identifier
ndc (package): 81746-183-01
ndc (package): 81746-183-00
ndc (product): 81746-183
ndc11 (package): 81746018301
ndc11 (package): 81746018300
spl id: 09e29758-29ad-1153-e063-6394a90ab827
spl set id: 32164318-7a7e-40b2-99da-8246c99fdbd3

Reported adverse events (FAERS/openFDA)#

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