FDA.reportPublic FDA data

NDC 66915-604 - Natural SPF 28

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
66915-604
Package NDCs from labels
66915-604-02, 66915-604-07, 66915-604-24, 66915-604-08, 66915-604-22, 66915-604-12, 66915-604-25, 66915-604-14, 66915-604-16, 66915-604-17, 66915-604-20, 66915-604-23, 66915-604-21, 66915-604-30
Manufacturer
CoValence, Inc. | CoValence, Inc
Effective date
2013-12-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Natural SPF 28 - CoValence, Inc. | CoValence, IncCoValence, Inc. | CoValence, Inc2013-12-02HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66915-604-02Natural SPF 28200000 g in 1 DRUMCREAM2000001
66915-604-07Natural SPF 28100 g in 1 BOTTLECREAM1001
66915-604-08Natural SPF 2870 g in 1 TUBECREAM701
66915-604-12Natural SPF 28120 g in 1 TUBECREAM1201
66915-604-14Natural SPF 2830 g in 1 BOTTLECREAM301
66915-604-16Natural SPF 2865 g in 1 JARCREAM651
66915-604-17Natural SPF 28135 g in 1 JARCREAM1351
66915-604-20Natural SPF 2870 g in 1 TUBECREAM701
66915-604-21Natural SPF 2830 g in 1 BOTTLECREAM301
66915-604-22Natural SPF 281 in 1 PACKAGECREAM11
66915-604-23Natural SPF 281 in 1 PACKAGECREAM11
66915-604-24Natural SPF 281 in 1 PACKAGECREAM11
66915-604-25Natural SPF 281 in 1 PACKAGECREAM11
66915-604-30Natural SPF 2830 g in 1 BOTTLECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66915-604NATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]114 package rows20131204_6ba4037f-13e2-4204-be87-bf06c73af4cd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37NATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1GNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
ALLANTOININACTIVE INGREDIENT344S277G0ZNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNANATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
COCO-CAPRYLATE/CAPRATEINACTIVE INGREDIENT8D9H4QU99HNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
DICAPRYLYL ETHERINACTIVE INGREDIENT77JZM5516ZNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POTNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
GLYCERYL ISOSTEARATEINACTIVE INGREDIENTHYE7O27HAONATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
ISONONYL ISONONANOATEINACTIVE INGREDIENTS4V5BS6GCXNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
LONICERA CAPRIFOLIUM FLOWERINACTIVE INGREDIENT5N1WD9784UNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
LONICERA JAPONICA FLOWERINACTIVE INGREDIENT4465L2WS4YNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
POLYGLYCERYL-6 DIOLEATEINACTIVE INGREDIENT062SZD3F3XNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0FNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
POPULUS TREMULOIDES BARKINACTIVE INGREDIENT5543O0CEIDNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4NATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
SOYBEAN OILINACTIVE INGREDIENT241ATL177ANATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
SQUALANEINACTIVE INGREDIENTGW89575KF9NATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
TRISODIUM ETHYLENEDIAMINE DISUCCINATEINACTIVE INGREDIENTYA22H34H9QNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
TROPOLONEINACTIVE INGREDIENT7L6DL16P1TNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RNATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENATURAL SPF 28 (ZINC OXIDE 11.6%, TITANIUM DIOXIDE 0.67%) CREAM [COVALENCE, INC.]1

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 239 of 296 · 5,905 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
meijer EXTRA STRENGTH Gas Relief SOFTGELSIMETHICONEMeijer, Inc.1befc6cb-a5ad-b950-e063-6394a90a5de32024-09-12WarningsExact identifier
unii: 92RU3N3Y1O
Diaper Rash Cream 5.6ozZINC OXIDEChina Ningbo Shangge Cosmetics Technology Corp.21a7c4ce-1360-931c-e063-6294a90aa66d2024-09-11WarningsExact identifier
unii: SOI2LOH54Z
Aveeno Skin Relief Moisturizing Fragrance FreeDIMETHICONEKenvue Brands LLC65476a2a-8cd4-4477-ac27-9a06f41e47112024-09-09WarningsExact identifier
unii: 92RU3N3Y1O
Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC17a7492b-5243-48c4-b808-5e9899db75302024-09-08WarningsExact identifier
unii: SOI2LOH54Z
meijer ULTRA STRENGTH Gas Relief SOFTGELSIMETHICONEMeijer, Inc.1bdbea4c-52f6-f855-e063-6394a90ae4fc2024-09-06WarningsExact identifier
unii: 92RU3N3Y1O
Proceuticals Private Label by TiZO tinted mineral sunscreen stickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd2179a2ff-9425-5b2c-e063-6294a90a45b62024-09-06WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
EltaMD UV Physical Rosy Tint SPF40TITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6bc4d2d4-ef62-4ec0-b514-17257603bac22024-09-05WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
FESTAL PLUSCELLULASE AP3 , PANCREATIN, SIMETHICONELydia Co., Ltd.212f5059-da04-595d-e063-6394a90acc642024-09-03WarningsExact identifier
unii: 92RU3N3Y1O
Diaper Rash Cream 15ozZINC OXIDERejoice International Corp.213213ab-f935-a62e-e063-6394a90af96b2024-09-03WarningsExact identifier
unii: SOI2LOH54Z
Diaper Rash Cream 5.6ozZINC OXIDERejoice International Corp.2133876b-eaf0-f988-e063-6394a90aae4d2024-09-03WarningsExact identifier
unii: SOI2LOH54Z
Simethicone 125 mgSIMETHICONEProficient Rx LP078ef54e-96b2-4e2f-bebc-9b9bcda1f90a2024-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEAdvanced Rx LLC72de768c-c011-433b-be27-f1978d18f7d82024-08-30WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEAdvanced Rx LLC57d31610-c658-49cf-9de3-01e8143aeace2024-08-30WarningsExact identifier
unii: 92RU3N3Y1O
Proceuticals Private Label by TiZO non-tinted mineral sunscreen stickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd20e86260-d641-c9ac-e063-6394a90ac07d2024-08-30WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
OS-01 Body SPF 30ZINC OXIDEONESKIN, INC20eb4d43-cf4d-dde3-e063-6394a90a6cb82024-08-30WarningsExact identifier
unii: SOI2LOH54Z
Freaks of Nature Peak Performance SPF50FREAKS OF NATURE PEAK PERFORMANCE SPF50Milbar Laboratories20b18cea-95e9-3527-e063-6294a90a4db42024-08-30WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
JACKET SPF-50 Broad Spectrum SunscreenZINC OXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBALSHI MD DERMACEUTICALSfcc45edd-098c-4f27-9712-0db36cfa0fdc2024-08-29WarningsExact identifier
unii: SOI2LOH54Z
SUDOCREM SKIN PROTECTANTZINC OXIDELEDA INNOVATIONS USA, INC.20d2cf0b-d237-fd78-e063-6394a90a8d032024-08-29WarningsExact identifier
unii: SOI2LOH54Z
QCH Maximum Strength Antacid 516ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.1794c35a-79c5-48c2-e063-6394a90a6d292024-08-28WarningsExact identifier
unii: 92RU3N3Y1O
dr. brandt SUN SHIELD SPF 50ZINC OXIDEDr. Brandt6f8af59b-d423-4250-8ddc-061fea886e3e2024-08-28WarningsExact identifier
unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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