FDA.reportPublic FDA data

NDC 49825-114-01 - Bioelements Sun Diffusing Protector SPF 15

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
49825-114
Requested NDC
49825-114-01
Package NDCs from labels
49825-114-01, 49825-114-02
Manufacturer
Bioelements Inc. | Bell International Laboratories, Inc.
Effective date
2012-01-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sun Diffusing Protector SPF 15Bioelements Inc. | Bell International Laboratories, Inc.2012-01-12HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49825-114-022020-01-31C16284748780-19d75b9d0-9796-f424-e053-dadaa90a57ceSun Diffusing Protector SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49825-114-01BioelementsSun Diffusing Protector SPF 15177 mL in 1 BOTTLECREAM1776
49825-114-02BioelementsSun Diffusing Protector SPF 151 in 1 BOXCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49825-114BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6Legacy NDC, 2 package rows20120127_6550938a-7299-4e4b-aafe-4d5ce13e79a5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
OCTISALATEACTIVE INGREDIENT4X49Y0596WBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
OCTINOXATEACTIVE MOIETY4Y5P7MUD51BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
OCTISALATEACTIVE MOIETY4X49Y0596WBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
OXYBENZONEACTIVE MOIETY95OOS7VE0YBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
CITRUS AURANTIUM FLOWER OILINACTIVE INGREDIENTD4BGE91OXHBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
CITRUS AURANTIUM FRUIT OILINACTIVE INGREDIENT59JDQ5VT0TBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
IMIDUREAINACTIVE INGREDIENTM629807ATLBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
SAGE OILINACTIVE INGREDIENTU27K0H1H2OBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
SORBITOLINACTIVE INGREDIENT506T60A25RBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKBIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.]6

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 8 of 401 · 8,005 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Zapper - Face pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3ee4feb3-6966-67f9-e063-6394a90a16d52026-08-17WarningsExact identifier
unii: SOI2LOH54Z
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Zinc OxideZINC OXIDEADUSA Distribution, LLC5940399c-31e3-6d51-e063-6294a90a8e7c2026-08-17Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Soleil Defense SunscreenBROAD SPECTRUM SPF 30AMARA MED SPA LLC594244b1-db3b-002b-e063-6394a90a03292026-08-17WarningsExact identifier
unii: 4X49Y0596W
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
SunscreenBROAD SPECTRUM SPF 30Charleston Dermatology, P.C.59440f7f-4213-6e2b-e063-6394a90af4832026-08-17WarningsExact identifier
unii: 4X49Y0596W
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Meraki Protective Mist SunscreenBROAD SPECTRUM SPF 30MERAKI MEDICAL SPA LLC59446224-0e97-ae2c-e063-6394a90a2a652026-08-17WarningsExact identifier
unii: 4X49Y0596W
CVS Health Infant Gas ReliefSIMETHICONECVS PHARMACY088993c1-31f0-4270-a3df-a585e7c8d5112026-08-17WarningsExact identifier
unii: 92RU3N3Y1O
Sun Zapper - Acne Pure Zinc Sunscreen SPF50ZINC OXIDEVeganic SKN Limited3ee435a5-70fb-0c8a-e063-6394a90a650a2026-08-16WarningsExact identifier
unii: SOI2LOH54Z
Sun Zapper - Anti-ageing pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3f1dc3b2-c289-5996-e063-6394a90ac6222026-08-16WarningsExact identifier
unii: SOI2LOH54Z
Mylanta Fall Harvest Collection Spiced Apple CiderCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a6040ff-1779-3215-e063-6294a90aaab12026-08-15WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Fall Harvest Collection Pumpkin SpiceCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a60a221-5b37-806e-e063-6394a90a5ccc2026-08-15WarningsExact identifier
unii: 92RU3N3Y1O
CVS PHARMACY Extra Strength Gas ReliefSIMETHICONE ANTIGASCVSb0fc2f24-cd63-4bb2-b9bb-a73449bcc1692026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
ISNTREE HYALURONIC ACID SENSITIVE SUNSCREENZINC OXIDEISNTREE Inc.58e38665-0bca-fb02-e063-6394a90ad62a2026-08-13WarningsExact identifier
unii: SOI2LOH54Z
TENA Proskin protective creamZINC OXIDEEssity HMS North America Inc.b840377f-a297-4aff-900e-7ea8b7c987172026-08-13Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
CVS PHARMACY Extra StrengthSIMETHICONECVS98db6216-897c-4cf6-a4b7-b913ae3a24962026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
CVS PHARMACY Gas reliefSIMETHICONECVSc2a3a978-c957-4453-88b3-53f4e80a24652026-08-13WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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