FDA.reportPublic FDA data

Light Day Sunscreen SPF 37

Product NDC
76458-301
11-digit product format
764580301
Labeler code
76458
Product ID
76458-301_0c8f2edd-e15a-3709-e063-6294a90a3b7b
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTINOXATE, OCTOCRYLENE
Dosage form
LOTION
Route
TOPICAL
Labeler
Circadia by Dr Pugliese, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-14
Substance
AVOBENZONE; OCTINOXATE; OCTOCRYLENE
Active strength
30; 75; 28 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Light Day Sunscreen SPF 37
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
OCTINOXATE75 mg/mL
OCTOCRYLENE28 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
16d76785-22a0-4a4b-a6f1-74056612e936Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76458-301-02Light Day Sunscreen SPF 371 in 1 BOXLOTION12
76458-301-02Light Day Sunscreen SPF 3759 mL in 1 BOTTLELOTION592
76458-301-08Light Day Sunscreen SPF 37236 mL in 1 BOTTLELOTION2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76458-301LIGHT DAY SUNSCREEN SPF 37 (AVOBENZONE, OCTINOXATE, OCTOCRYLENE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]2Current NDC, Legacy NDC, 3 package rows20231216_16d76785-22a0-4a4b-a6f1-74056612e936.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 278 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Sunscreen SPORT SPF 100AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONEWalmart Stores Inc.4fc58cea-082a-4535-9c51-8e7dedc15be32024-10-16WarningsExact identifier
application number: M020
Equate Sunscreen SPF 50 KIDS Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDEWAL-MART STORES INC81cb6b2e-1ca3-4a83-a8df-9bfee61e79af2024-10-16WarningsExact identifier
application number: M020
Equate Sunscreen SPF100 SPORT Broad SpectrumAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONEWAL-MART STORES INC1ce4839b-f693-4653-8fe2-444df76eb83c2024-10-16WarningsExact identifier
application number: M020
Equate Sunscreen Mineral Based KIDS Broad Spectrum spf 50HOMOSALATE , OCTOCRYLENE, ZINC OXIDEWal-Mart Stores Inc0cdfc3a1-4bfa-474d-a4eb-4bfa1e628c892024-10-16WarningsExact identifier
application number: M020
EQUATE Sunscreen BABY Broad Spectrum SPF 50AVOBENZONE HOMOSALATE OCTOCRYLENEWAL-MART STORES INCb2083cbd-ef19-4edc-9d7d-eca3452ee0ee2024-10-16WarningsExact identifier
application number: M020
Equate-Sunscreen Broad Spectrum SPF 50 ULTRAAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEWal-Mart Stores Incbbe06f23-0d0f-43ff-9d1b-37a99d9d62062024-10-16WarningsExact identifier
application number: M020
BIG LOTS SOUNDBODY SPF 50 SPORT SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBIG LOTS STORES, INC.c8c1c904-12f5-48e0-e053-2a95a90a9f752024-10-16WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 70 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEBIG LOTS STORES, INC.e717ec77-8beb-645a-e053-2a95a90ac11b2024-10-16WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 50 Ultra Sport SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENEBIG LOTS STORES, INC.f0dcb5d8-a3e5-4334-e053-2995a90a535a2024-10-16WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 30 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE,BIG LOTS STORES, INC.c8aede4f-3d84-63d1-e053-2a95a90afb1a2024-10-16WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 70 Sun DefenseAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEBIG LOTS STORES, INC.db3ad809-d6c9-6c83-e053-2a95a90ac58b2024-10-16WarningsExact identifier
application number: M020
BIG LOTS SOUNDBODY KIDS SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBIG LOTS STORES, INC.e4b70fdb-7548-175c-e053-2995a90adfe62024-10-16WarningsExact identifier
application number: M020
BIOLUMIN-C HEAT AGING PROTECTOR SPF50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.38d0b78b-bd8e-4cb0-925a-19adff550c192024-10-16WarningsExact identifier
application number: M020
Vanicream Facial Moisturizer Broad Spectrum SPF30ZINC OXIDEPharmaceutical Specialties Incd8c9a8d0-1f24-2240-e053-2a95a90a8dee2024-10-15WarningsExact identifier
application number: M020
Mula Maldives SPF 30 Moisturizing SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEMula Maldives PVT LTDf9be092f-8d53-4bb2-8363-81c003da42d62024-10-15WarningsExact identifier
application number: M020
Kroger Invisible Sunscreen SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE KROGER COMPANYf71ee1cd-e075-9ee9-e053-6394a90a8f9f2024-10-15WarningsExact identifier
application number: M020
Kroger Sunscreen Oil SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE KROGER COMPANYf76e12aa-9d98-5694-e053-6294a90a52562024-10-15WarningsExact identifier
application number: M020
Kroger Sport Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATETHE KROGER COMPANYf0f350f4-b1b9-f4d3-e053-2995a90ac4592024-10-15WarningsExact identifier
application number: M020
Kroger Shimmer Sunscreen Hydrating SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENETHE KROGER COMPANYf76fe840-0da2-a903-e053-6294a90a05ee2024-10-15WarningsExact identifier
application number: M020
MINERAL BASED SPF 50 SUNSCREENZINC OXIDE, TITANIUM DIOXIDETHE KROGER COMPANYa4e6936d-a76c-e8fd-e053-2995a90a965f2024-10-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76458-301-02764580301021 BOTTLE in 1 BOX (76458-301-02) / 59 mL in 1 BOTTLE1 bottle2020-02-140000-00-00NoNoCurrent
76458-301-0876458030108236 mL in 1 BOTTLE (76458-301-08) 236 ml2020-02-140000-00-00NoNoCurrent