FDA.reportPublic FDA data

Oil-Free Daily Hydration SPF 15

Product NDC
76151-105
11-digit product format
761510105
Labeler code
76151
Product ID
76151-105_2d025da2-1f3a-2062-e063-6294a90ab9e9
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, AVOBENZONE
Dosage form
CREAM
Route
TOPICAL
Labeler
Boscia LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-04-16
Substance
OCTINOXATE; AVOBENZONE
Active strength
50; 30 mg/mL; mg/mL
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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76151-105-52UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76151-105-11UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76151-105-52UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76151-105-11UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76151-105-52UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76151-105-11UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage76151-105-52EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage76151-105-11EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
Oil-Free Daily Hydration SPF 15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE50 mg/mL
AVOBENZONE30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ec322ae5-ab03-4c7b-9c6d-0bda3327c72aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
76151-105-112025-02-01Oil-Free Daily Hydration SPF 15
76151-105-522025-02-01Oil-Free Daily Hydration SPF 15
76151-105-112025-01-30Oil-Free Daily Hydration SPF 15
76151-105-522025-01-30Oil-Free Daily Hydration SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76151-105-11Oil-Free Daily Hydration SPF 1540 mL in 1 TUBECREAM409
76151-105-52Oil-Free Daily Hydration SPF 1515 mL in 1 TUBECREAM159

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXOIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51OIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXOIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51OIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0OIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1
ARCTIUM LAPPA ROOTINACTIVE INGREDIENT597E9BI3Z3OIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAOIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1
CITRUS AURANTIUM FLOWERINACTIVE INGREDIENTO730ZX2Z83OIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOPINACTIVE INGREDIENT08H094218DOIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXOIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)INACTIVE INGREDIENT8136Y38GY5OIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGOIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1
PHELLODENDRON AMURENSE BARKINACTIVE INGREDIENTPBG27B754GOIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1
POTASSIUM PHOSPHATEINACTIVE INGREDIENTB7862WZ632OIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1
ROSEMARYINACTIVE INGREDIENTIJ67X351P9OIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1
WATERINACTIVE INGREDIENT059QF0KO0ROIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZOIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76151-105OIL-FREE DAILY HYDRATION SPF 15 (OCTINOXATE, AVOBENZONE) CREAM [BOSCIA LLC]9Current NDC, Legacy NDC, 2 package rows20250201_ec322ae5-ab03-4c7b-9c6d-0bda3327c72a.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 9 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Continuous Correction CreamHOMOSALATE 10% OCTISALATE 4.9% OCTOCRYLENE 4%Baxter of California, LLC14b05c8c-0398-2973-e063-6394a90a8a862026-07-31WarningsExact identifier
application number: M020
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
application number: M020
MELAO GHK-Cu PEPTIDE SUNSCREENBUTYL METHOXYDIBENZOYLMETHANE,ETHYLHEXYL SALICYLATE,HOMOSALATE,OCTOCRYLENEGuangdong Aimu Biological Technology Co., Ltd57a8c34a-d6c9-c03e-e063-6394a90a7af12026-07-29WarningsExact identifier
application number: M020
BelleJoss BROAD SPECTRUM SPF 50BROAD SPECTRUM SPF 50Guangzhou Liyan Cosmetics Technology Co., Ltd.57c07f29-2e23-d18a-e063-6394a90a10202026-07-29WarningsExact identifier
application number: M020
BemeJolie BROAD SPECTRUM SPF 50BROAD SPECTRUM SPF 50Guangzhou Liyan Cosmetics Technology Co., Ltd.57c27cea-bb0c-5d2d-e063-6394a90a1b482026-07-29WarningsExact identifier
application number: M020
DeFlameALLANTOINNoon Aesthetics M.R. Ltd2628bd73-0ca9-497b-bcd9-088444cd62be2026-07-28WarningsExact identifier
application number: M020
Native Mineral Suncare Broad Spectrum SPF 30 UnscentedZINC OXIDEThe Procter & Gamble Manufacturing Company3a89238b-d1ee-d7fa-e063-6294a90ae55f2026-07-28WarningsExact identifier
application number: M020
First Aid Beauty FAB Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Companydfb1b42e-c821-1a41-e053-2995a90acf952026-07-28WarningsExact identifier
application number: M020
HEB 50 Pumpkin Spice Latte Scent SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B.579f3274-398e-7eab-e063-6394a90afe352026-07-27WarningsExact identifier
application number: M020
LUXE COLOR FOUNDATIONOCTINOXATE 7% ZINC OXIDE 5%Guangzhou Huixue Biotechnology Co., Ltd.576c3496-702f-808c-e063-6394a90a53c32026-07-25WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25 KitAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEXact Packing Limited5759058d-e683-f3fc-e063-6394a90abc012026-07-24WarningsExact identifier
application number: M020
No7 Future Renew Defense Shield SPF 50AVOBENZONE, OCTINOXATE, OCTISALATEXact Packing Limited5758b79f-6386-bbea-e063-6394a90aeb342026-07-24WarningsExact identifier
application number: M020
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
application number: M020
SERVE AND PRIME SUNSCREEN BROAD SPECTRUM SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEESTEE LAUDER INC575fc04a-794a-93e7-e063-6394a90a7e672026-07-24WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHTZINC OXIDEYounique, LLCf93d42a9-b655-4b75-a16d-b29f38f04efc2026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT MEDIUMZINC OXIDEYounique, LLC82769819-b229-4864-9b3c-44f49a68a53a2026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIRZINC OXIDEYounique, LLCed700cae-8226-48d9-93ba-03154aa1cae52026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR LIGHTZINC OXIDEYounique, LLCd728b89c-692f-485b-88c3-929b2f0350d52026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUMZINC OXIDEYounique, LLCa49dfff1-e9ec-4573-90b0-ef6a7226aa562026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM DARKZINC OXIDEYounique, LLCcc576b63-caf4-491d-8d7f-027b1127133b2026-07-23WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76151-105-117615101051140 mL in 1 TUBE (76151-105-11) 40 ml2017-12-190000-00-00NoNoCurrent
76151-105-527615101055215 mL in 1 TUBE (76151-105-52) 15 ml2017-12-190000-00-00NoNoCurrent