FDA.reportPublic FDA data

ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50)

Product NDC
81746-183
11-digit product format
817460183
Labeler code
81746
Product ID
81746-183_09e29758-29ad-1153-e063-6394a90ab827
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTINOXATE, OCTISALATE, ZINC OXIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
ZITSTICKA, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-10
Substance
HOMOSALATE; OCTINOXATE; OCTISALATE; ZINC OXIDE
Active strength
75; 75; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE75 mg/mL
OCTINOXATE75 mg/mL
OCTISALATE50 mg/mL
ZINC OXIDE30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
32164318-7a7e-40b2-99da-8246c99fdbd3Available on FDA.report

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

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 33 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Target Up and Up SPF 50 Coconut Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION51510195-a577-dce4-e063-6294a90a3e742026-05-08WarningsExact identifier
application number: M020
Target Up and Up SPF 50 Watermelon Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION5151493a-c25a-fb59-e063-6394a90a10342026-05-08WarningsExact identifier
application number: M020
Target Up and Up SPF 50 Strawberry Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION51512b9f-514d-3a29-e063-6294a90ae1732026-05-08WarningsExact identifier
application number: M020
Target Up and Up SPF 50 Peony Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION5151560f-350c-88c3-e063-6294a90a34922026-05-08WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbb65c8d7-318f-4d52-9d74-ca22ce3896382026-05-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 CassetteCIELE LIP AND PROTECT LIPSTICK SPF 60 CASSETTELE COSMETICS INC5139cc37-62ac-514b-e063-6394a90a9ca32026-05-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 KellyCIELE LIP AND PROTECT LIPSTICK SPF 60 KELLYLE COSMETICS INC5139d3c1-83d1-2ad9-e063-6394a90a69582026-05-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 MargauxCIELE LIP AND PROTECT LIPSTICK SPF 60 MARGAUXLE COSMETICS INC5138eb74-0223-6c1f-e063-6294a90a3bc62026-05-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 BonnieCIELE LIP AND PROTECT LIPSTICK SPF 60 BONNIELE COSMETICS INC513a0449-5494-5dfd-e063-6394a90a026e2026-05-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 LouLouCIELE LIP AND PROTECT LIPSTICK SPF 60 LOULOULE COSMETICS INC5139dab1-3c27-a59e-e063-6294a90a70962026-05-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 PuzzleCIELE LIP AND PROTECT LIPSTICK SPF 60 PUZZLELE COSMETICS INC513a0722-42ab-1051-e063-6294a90a8a1d2026-05-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 SaddleCIELE LIP AND PROTECT LIPSTICK SPF 60 SADDLELE COSMETICS INC513a12cf-0230-6a24-e063-6394a90afb952026-05-07WarningsExact identifier
application number: M020
Target Up and Up SPF 50 Banana Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION513bdfb1-6b90-dfc7-e063-6394a90a9ec22026-05-07WarningsExact identifier
application number: M020
Zinc Oxide 20.00%SPF 50 MINERALCoconut Caliente Costa Rica LLC388f1e01-0feb-4c94-88a7-13c81368c6c82026-05-07WarningsExact identifier
application number: M020
SPF 50 Kids SunscreenHOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%Coconut Caliente Costa Rica LLC9839570f-eeef-4140-a6ca-9fd2c9767a5b2026-05-07WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior67b90f00-4c82-40cd-af96-f8dedf95f8af2026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7a2bd17d-0ea7-4326-9939-a747869c01d22026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora396c0eb-f91f-4732-9c20-6b25aa0634b72026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior18b21fba-f6ee-4ac5-a536-096716f51da02026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior13c34bba-f939-4aa7-9457-9d6025902e062026-05-06WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81746-183-00817460183001 BOTTLE, DROPPER in 1 BOX (81746-183-00) / 50 mL in 1 BOTTLE, DROPPER2021-04-100000-00-00NoNoCurrent
81746-183-01817460183011 BOTTLE, DROPPER in 1 BOX (81746-183-01) / 30 mL in 1 BOTTLE, DROPPER2021-09-010000-00-00NoNoCurrent