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; OCTISALATE; OXYBENZONE; ZINC OXIDE
Active strength
50; 30; 25; 43 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
OCTISALATE30 mg/g
OXYBENZONE25 mg/g
ZINC OXIDE43 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Y5P7MUD51, 4X49Y0596W, 95OOS7VE0Y, SOI2LOH54Z

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52993-001-032020-12-11C16284748780-19d75b9d1-002d-f424-e053-dadaa90a57ceZinka Clear Zinc Oxide Sunscreen
52993-001-032020-12-11C16284748780-19d75b9d1-002d-f424-e053-dadaa90a57ceZinka Clear Zinc Oxide Sunscreen
52993-001-032020-01-31C16284748780-19d75b9d1-002d-f424-e053-dadaa90a57ceZinka Clear Zinc Oxide Sunscreen
52993-001-032020-01-31C16284748780-19d75b9d1-002d-f424-e053-dadaa90a57ceZinka 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

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