FDA.reportPublic FDA data

Zinka Clear Zinc Oxide Sunscreen

Product NDC
52993-001
11-digit product format
529930001
Labeler code
52993
Product ID
52993-001_4354515e-3730-41be-e063-6294a90afc67
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Zinc Oxide, Octisalate, Oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Zinka, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-03-01
Substance
OCTINOXATE; ZINC OXIDE; OCTISALATE; OXYBENZONE
Active strength
50; 43; 30; 25 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage52993-001-03e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52993-001-039bebd1f3094a…5416666fcb17…

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
Zinka Clear Zinc Oxide Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE50 mg/g
ZINC OXIDE43 mg/g
OCTISALATE30 mg/g
OXYBENZONE25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
SOI2LOH54ZInternal UNII lookup
4X49Y0596WInternal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7b097f5e-8127-49e6-8a77-4ee1fded5ff1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-12-11Zinka Clear Zinc Oxide Sunscreen
2020-12-11Zinka Clear Zinc Oxide Sunscreen
2020-01-31Zinka Clear Zinc Oxide Sunscreen
2020-01-31Zinka Clear Zinc Oxide Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52993-001-03Zinka Clear Zinc Oxide Sunscreen85.1 g in 1 TUBELOTION85.17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51ZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51ZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
CETYL DIMETHICONE 150INACTIVE INGREDIENT5L694Y0T22ZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4ZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATEINACTIVE INGREDIENTG3232Z5S2OZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309ZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
HYDROGENATED POLYBUTENE (370 MW)INACTIVE INGREDIENTV5H8103878ZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SABZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52993-001ZINKA CLEAR ZINC OXIDE SUNSCREEN (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ZINKA, INC.]5Current NDC, Legacy NDC, 1 package rows20241210_7b097f5e-8127-49e6-8a77-4ee1fded5ff1.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 5 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC5990fe66-4fa2-06aa-e063-6294a90a52612026-08-21WarningsExact identifier
application number: M020
Hawaiian TropicAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC5991466a-e729-16b7-e063-6394a90a11ff2026-08-21WarningsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC597b78df-83cb-1b21-e063-6294a90a56a82026-08-20Warnings, Adverse reactionsExact identifier
application number: M020
Sunski Base Camp Face and Body Sunscreen SPF 45HOMOSALATE, OCTISALATE, AVOBENZONEStewart Charley Ventures, LLC2fc45f85-a6f8-4893-8b34-4db5e39cb6152026-08-20WarningsExact identifier
application number: M020
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 30Concierge Choice LLC5980055b-493e-4763-e063-6294a90a570f2026-08-20WarningsExact identifier
application number: M020
Lip Balm SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENESkin Script, LLC20c5fde7-ee8f-4b74-e063-6394a90a93ec2026-08-19WarningsExact identifier
application number: M020
Aloe UP .5OZ SPF 50 MINERAL SunscreenZINC OXIDE 14.69%Aloe Care International, LLC6ad80af3-78cd-4211-a5f2-68531aae264a2026-08-19WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 50 Tinted Sunscreen-StickZINC OXIDEUtu Co596e17d3-3064-1cda-e063-6294a90af9632026-08-19WarningsExact identifier
application number: M020
Mineral sunscreenMINERAL SUNSCREENGuangzhou Origin Beauty Cosmetics Co., Ltd.59713657-a7ef-1aee-e063-6394a90a326e2026-08-19WarningsExact identifier
application number: M020
The Naked Bee SPF 50 Mineral SunscreenZINC OXIDE 14.69%The Naked Beef820a9be-c94d-4fd5-b202-2dda5746a82a2026-08-18WarningsExact identifier
application number: M020
The Naked Bee SPF 50 Mineral SunscreenZINC OXIDE 20%The Naked Bee7dd2b1cd-e229-4eeb-8122-46fde5af10912026-08-18WarningsExact identifier
application number: M020
Sun Zapper - Baby pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3ee52faa-64a8-4bdf-e063-6294a90a65cf2026-08-17WarningsExact identifier
application number: M020
Sun Zapper - Face pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3ee4feb3-6966-67f9-e063-6394a90a16d52026-08-17WarningsExact identifier
application number: M020
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
application number: M020
Soleil Defense SunscreenBROAD SPECTRUM SPF 30AMARA MED SPA LLC594244b1-db3b-002b-e063-6394a90a03292026-08-17WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
application number: M020
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 30Charleston Dermatology, P.C.59440f7f-4213-6e2b-e063-6394a90af4832026-08-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52993-001-035299300010385.1 g in 1 TUBE (52993-001-03) 85.1 g2016-09-200000-00-00NoNoCurrent