FDA.reportPublic FDA data

Broad Spectrum SPF 50 Sunscreen

Product NDC
49825-133
11-digit product format
498250133
Labeler code
49825
Product ID
49825-133_511ea5f5-7cbd-495f-b252-fbe14ae0bf7c
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Ocinoxate, Octisalate, Octocrylene, Oxybenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
Bioelements
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-07-11
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49825-133-022020-01-31C16284748780-19d75b9d0-596b-f424-e053-dadaa90a57ceSPF 50 FaceScreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49825-133-01Broad Spectrum SPF 50 SunscreenBioelements68 mL in 1 JARCREAM685
49825-133-02Broad Spectrum SPF 50 SunscreenBioelements1 in 1 BOXCREAM15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
HOMOSALATEACTIVE INGREDIENTV06SV4M95SBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51BROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
OCTISALATEACTIVE INGREDIENT4X49Y0596WBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
AVOBENZONEACTIVE MOIETYG63QQF2NOXBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
HOMOSALATEACTIVE MOIETYV06SV4M95SBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
OCTINOXATEACTIVE MOIETY4Y5P7MUD51BROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
OCTISALATEACTIVE MOIETY4X49Y0596WBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
OXYBENZONEACTIVE MOIETY95OOS7VE0YBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
1,3-BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RABROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
ANGELICA SINENSIS ROOTINACTIVE INGREDIENTB66F4574UGBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
ASIAN GINSENGINACTIVE INGREDIENTCUQ3A77YXIBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
CENTELLA ASIATICAINACTIVE INGREDIENT7M867G6T1UBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
CETYL DIMETHICONE 25INACTIVE INGREDIENTU4AS1BW4ZBBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
NASTURTIUM OFFICINALEINACTIVE INGREDIENTYH89GMV676BROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
RHUS GLABRA BARKINACTIVE INGREDIENT7XC0E9WP6UBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
STEARETH-2INACTIVE INGREDIENTV56DFE46J5BROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
STEARETH-21INACTIVE INGREDIENT53J3F32P58BROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5
WATERINACTIVE INGREDIENT059QF0KO0RBROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49825-133BROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS]5Legacy NDC, 2 package rows20150128_51259d41-610c-4372-91ba-2f4c02e9b42d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49825-133-014982501330168 mL in 1 JAR68 mlHistorical
49825-133-02498250133021 in 1 BOXHistorical