FDA.reportPublic FDA data

LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35

Product NDC
42472-010
11-digit product format
424720010
Labeler code
42472
Product ID
42472-010_288e9b21-c175-8b84-e063-6394a90ac3b1
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTISALATE, and OXYBENZONE
Dosage form
LOTION
Route
TOPICAL
Labeler
Aramis Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-12-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE
Active strength
.03; .05; .045; .033 g/mL; g/mL; g/mL; g/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE.03 g/mL
HOMOSALATE.05 g/mL
OCTISALATE.045 g/mL
OXYBENZONE.033 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8b206b6d-92e4-48bc-a40c-93ffdd635535Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-08-02LAB SERIES DAY RESCUE DEFENSE LOTION BROAD SPECTRUM SPF 35
2022-07-29LAB SERIES DAY RESCUE DEFENSE LOTION BROAD SPECTRUM SPF 35
2021-08-02LAB SERIES DAY RESCUE DEFENSE LOTION BROAD SPECTRUM SPF 35
2021-07-23LAB SERIES DAY RESCUE DEFENSE LOTION BROAD SPECTRUM SPF 35

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42472-010-01LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 351 in 1 CARTONLOTION17
42472-010-01LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35100 mL in 1 TUBELOTION1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42472-010LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35 (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONE) LOTION [ARAMIS INC.]7Current NDC, Legacy NDC, 2 package rows20241208_8b206b6d-92e4-48bc-a40c-93ffdd635535.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 69 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALOE KOTE SPF 25OCTINOXATE, OXYBENZONE, HOMOSALATEAloe Care International, LLC12e78c53-ba19-4c8e-bd2f-8c85fccbc1792026-01-26WarningsExact identifier
application number: M020
ALOE UP KIDS SPORT SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC62016e94-b5d2-4ba2-ab9c-b0b2c1ead6502026-01-26WarningsExact identifier
application number: M020
Homosalate 10 Avobenzone 3% Octocrylene 6%SPF 45 FACES&C Hampton Sun LLCe49808c9-5025-4965-8679-7fe824cf69072026-01-26WarningsExact identifier
application number: M020
ENVIRONMENTAL DEFENSEZINC OXIDEAvasol LLC1fbddab4-71f7-4167-ad21-30040b7c71bb2026-01-26WarningsExact identifier
application number: M020
Surfers BarrierZINC OXIDEAvasol LLCd6e2ac0a-3bf6-4d08-8647-6a23de2ac8572026-01-26WarningsExact identifier
application number: M020
SURFERS BARRIER SPF 50ZINC OXIDE, TITANIUM DIOXIDEAvasol LLCec55eef0-17e6-416d-bd5e-548f2f323cea2026-01-26WarningsExact identifier
application number: M020
Zenskin Watery Dew Nia-Cica SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUNSCREENZenskin Co. Ltd.49584899-d523-9677-e063-6394a90a14032026-01-26WarningsExact identifier
application number: M020
Caring mill sun serum with Vitamin C NiacinamideHOMOSALATE OCTOCRYLENE OCTISALATE AVOBENZONEFSA Store lnc.4931ee71-1088-1ac1-e063-6294a90ad82b2026-01-25WarningsExact identifier
application number: M020
Caring mill Mineral Eye CreamZINC OXIDEFSA STORE INC.4932ea19-28cc-b245-e063-6394a90ac7aa2026-01-25WarningsExact identifier
application number: M020
Ceile SPF 30 prime PROTECT Broad Spectrum SPF 30 SunscreenSUNSCREEN 30 MINERALLE COSMETICS INC2cee0413-d532-c192-e063-6294a90aa8232026-01-25WarningsExact identifier
application number: M020
BeginS by JUNGSAEMMOOL Blue Chamomile Hyaluronic Acid Aqua Sunscreen Broad Spectrum SPF 50 plusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJungsaemmool Beauty Co., Ltd.62e23503-7233-434a-91f0-092f10d2717d2026-01-24WarningsExact identifier
application number: M020
BeginS by JUNGSAEMMOOL Blue Chamomile Hyaluronic Acid Airy Sun Stick Broad Spectrum SPF 50 plusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJungsaemmool Beauty Co., Ltd.030a20fb-4846-4a5c-9808-a399aac2ff0b2026-01-24WarningsExact identifier
application number: M020
Mimosa Lane SPF45OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREENR&G Divergency LLC40f3b8ea-bfa5-4c66-9c79-c4408bda857a2026-01-24WarningsExact identifier
application number: M020
111 SKIN SUNSCREEN SPF 50ZINC OXIDEBentley Laboratories, LLCb1265797-71dd-4302-ab26-dbff6ccec8562026-01-23WarningsExact identifier
application number: M020
Mania Holic Sunscreen PackOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEFirstmarket Co., ltd.b95a460c-1f7b-4193-b305-466e073af6402026-01-23WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 320HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.1cdbae71-441b-426d-99ee-c889d76af4522026-01-23WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 250HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.8f4b5e0a-4578-4af3-b7d9-a19d4eb732e72026-01-23WarningsExact identifier
application number: M020
ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PATITANIUM DIOXIDELG Household and Healthcare, Inc.65e70306-9e79-494d-9217-a43002f163072026-01-23WarningsExact identifier
application number: M020
O HUI Sun Science Ideal Cover Sunscreen Broad SpectrumTITANIUM DIOXIDELG Household and Healthcare, Inc.c15ffd23-271d-458d-9048-9bc50331d5d72026-01-23WarningsExact identifier
application number: M020
Aqua protection Sunscreen Broad Spectrum SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.627e6ea5-016b-4ab6-a50c-aa9c27e5cca12026-01-23WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42472-010-01424720010011 TUBE in 1 CARTON (42472-010-01) / 100 mL in 1 TUBE1 tube2016-12-010000-00-00NoNoCurrent