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 308 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Garnier green labs Pore Perfecting CannaB Serum Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc21d9b6dc-6f99-4af4-a838-c762c3fb9e3a2024-01-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Hydraphase UV Intense Moisturizer Broad Spectrum SPF 20 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incad4f45b2-3391-4e32-9744-28838727260c2024-01-01WarningsExact identifier
application number: M020
La Roche Posay New 50 Body and Face SPF 50 Mineral Anthelios Gentle 100 percent mineral UV filters Soft finish with Cell Ox ShieldTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incc0f7ae46-7161-4d48-9386-007bfafecfd52024-01-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios HA Mineral Broad Spectrum SPF 30 Daily Moisturizing SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc7bca5947-88a3-4cb3-a6f2-9fa389d344ef2024-01-01WarningsExact identifier
application number: M020
LOreal Paris Revitalift Miracle Blur Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc45eb17f4-6fc0-4e6d-a905-78581175de952024-01-01WarningsExact identifier
application number: M020
LOreal Paris Skin Expert Revitalift Bright Reveal Brightening Day Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc454e4b9a-4ddf-44cf-8ee9-abab6f5744242024-01-01WarningsExact identifier
application number: M020
Kiehls Super Fluid Daily UV Defense SPF 50 plus Anti-Pollution Lightweight Formula for All Skin TypesAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc5bbd9e40-3b80-4ecb-b1d4-0110904135342024-01-01WarningsExact identifier
application number: M020
Garnier SkinActive Clearly Brighter AntiSun Damage Daily Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSLATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc1d33dc1d-40d5-4a85-8dfe-708bfb9da5382024-01-01WarningsExact identifier
application number: M020
Vichy Laboratoires Aqualia Thermal UV Defense Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc.08bcee1c-399a-4ec8-84cf-b5e83c4fa6652024-01-01WarningsExact identifier
application number: M020
LOreal Paris Skin Paradise Water Infused Tinted Moisturizer Broad Spectrum SPF 19 SunscreenENSULIZOLEL'Oreal USA Products Inc913116de-1abf-4844-8611-1db1b093ad002024-01-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc8a2fd46c-5767-4621-8e69-dd291f9fe5b12024-01-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Daily Tone Correcting Primer Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc89b59bd7-9a91-4b99-84e7-996a8b1d499e2024-01-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Clear Skin Face Oil Free Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Ince1310453-1880-43a5-982b-cf9b30cfdc472024-01-01WarningsExact identifier
application number: M020
Kiehls Since 1851 Super Multi Corrective Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc733e7853-ab11-4887-83a2-b9d95c1634532024-01-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Melt In Sunscreen Milk Broad Spectrum SPF 60 Face and BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc53ab6046-058b-4cdf-8e4e-7ce6f52887012023-12-31WarningsExact identifier
application number: M020
CeraVe Developed with Dermatologists Skin Renewing Broad Spectrum SPF 30 DayOCTINOXATE AND ZINC OXIDEL'Oreal USA Products Inc.50542a3b-2ef0-452f-b463-79b41e10d1e02023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc6d3c5fc5-c818-46c4-8db3-cffcdcd56e062023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Sport Anthelios Activewear Broad Spectrum SPF 60 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc071bfb80-d980-4e62-9cd6-96149f1ba04a2023-12-31WarningsExact identifier
application number: M020
Garnier green labs Brightening Serum PineaC Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc9302bccb-636d-45f1-8919-9b98c2e685672023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Daily Antiaging Primer with SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc6b65d6d9-7ff3-4c84-986e-ef180161eadb2023-12-31WarningsExact 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