FDA.reportPublic FDA data

Advanced Day Ultimate Protect Sunscreen SPF 50

Product NDC
79988-002
11-digit product format
799880002
Labeler code
79988
Product ID
79988-002_29071920-ba91-871a-e063-6294a90aee27
Type
HUMAN OTC DRUG
Nonproprietary name
Butyl Methoxydibenzoylmethane, Ethylhexyl Salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
Medik8 Limited
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-06
Substance
ETHYLHEXYL SALICYLATE; OCTOCRYLENE; HOMOSALATE; BUTYL METHOXYDIBENZOYLMETHANE
Active strength
4.8; 9.5; 10; 2.8 g/100mL; g/100mL; g/100mL; g/100mL
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
Advanced Day Ultimate Protect Sunscreen SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETHYLHEXYL SALICYLATE4.8 g/100mL
OCTOCRYLENE9.5 g/100mL
HOMOSALATE10 g/100mL
BUTYL METHOXYDIBENZOYLMETHANE2.8 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal 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
29071920-ba90-871a-e063-6294a90aee27Available 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
79988-002-05Advanced Day Ultimate Protect Sunscreen SPF 505 mL in 1 BOTTLECREAM51
79988-002-50Advanced Day Ultimate Protect Sunscreen SPF 5050 mL in 1 BOTTLECREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79988-002ADVANCED DAY ULTIMATE PROTECT SUNSCREEN SPF 50 (BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE) CREAM [MEDIK8 LIMITED]1Current NDC, 2 package rows20250109_29071920-ba90-871a-e063-6294a90aee27.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 201 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Counter Beauty Dew Skin Tinted Moisturizer No. 1ZINC OXIDEG2G Ventures, PBC3a2676ed-087d-f957-e063-6294a90ad4572025-07-17WarningsExact identifier
application number: M020
Sjolie Tanning SPF 30 SunscreenZINC OXIDESJOLIE, INC.3a283a09-2edb-f92c-e063-6294a90a82bd2025-07-17WarningsExact identifier
application number: M020
Neutrogena Clear Body Breakout Free Oil Free Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC32889c1e-d539-4b36-b012-9789c4a8d6422025-07-16WarningsExact identifier
application number: M020
GZE Tinted SunscreenZINC OXIDE 3%Guangzhou Yilong Cosmetics Co.,Ltd.182612d8-76a4-44a1-e063-6394a90a8d5f2025-07-15WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC089b798b-829f-aa86-e063-6294a90a86312025-07-15WarningsExact identifier
application number: M020
MO HANDSOME Protection Sport Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENE8 PINE DESIGN LLC982ada30-5f87-42c6-b9ea-fedd842aa09d2025-07-15WarningsExact identifier
application number: M020
Amarte ULTRA VEIL DailySUNSCREENAmarte USA LLC39e9ca98-d0e8-6b8f-e063-6394a90aa3662025-07-15WarningsExact identifier
application number: M020
Amarte ULTRA VEIL BB FairSUNSCREENAmarte USA LLC39e87950-4103-c2eb-e063-6394a90a05522025-07-15WarningsExact identifier
application number: M020
LEBELAGE UV SUN ULTRA SHIELD SUNSTICKAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATEDONGDONGGURIMOO CO.,LTD.39eea41c-8703-cf1f-e063-6394a90a5b1f2025-07-14WarningsExact identifier
application number: M020
Basin Vanilla SPF 30 Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.4a8e7be0-97a6-ada5-e063-6294a90ae25a2025-07-14WarningsExact identifier
application number: M020
Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc48980ef3-ebda-450e-9f15-effad27dec9a2025-07-11WarningsExact identifier
application number: M020
KLARINA Sheer Mineral Sunscreen Blender SPF 50ZINC OXIDEKLARINA INC081941e3-02da-43a2-bf6f-a6d0f053272f2025-07-10WarningsExact identifier
application number: M020
ATHLETIC COSMETIC COMPANY Clear Power Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEATHLETIC COSMETIC COMPANY LLCf143a8e0-b32b-4b14-a6ae-f013627b484c2025-07-10WarningsExact identifier
application number: M020
Venofye Orchard Bee Brilliance SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONEInnovation Brands Inc.7c36c7e5-bc0b-40e6-bdbc-fd34f0b0eafe2025-07-10WarningsExact identifier
application number: M020
Touch Anti-Aging SPF 30 MoisturizerZINC OXIDE, OCTINOXATE, AND OCTISALATEDiractions Capital LLC47ce948e-5848-43a1-880e-aeb78e9ad1b32025-07-10WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc06f2ced8-273e-454f-92b4-2846f6674b372025-07-10WarningsExact identifier
application number: M020
SPF30 unseen sunscreen 01BUTYL METHOXYDIBENZOYLMETH, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENECosmuses Cosmetics (Ningbo) Co., Ltd.398bb1f5-80ea-c589-e063-6294a90abefd2025-07-09WarningsExact identifier
application number: M020
Prada Reveal Skin Optimizing Foundation Broad Spectrum SPF 17 SunscreenENSULIZOLESICOS ET CIE1ac50772-0bea-4a41-8300-03f65f0bed522025-07-09WarningsExact identifier
application number: M020
Prada Reveal Skin Optimizing Foundation Broad Spectrum SPF 17 SunscreenENSULIZOLEL'Oreal USA Products Ince74a8c43-ec70-4de1-b2b5-0e89e40bfb402025-07-08WarningsExact identifier
application number: M020
IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc.84fbbb01-bb16-41a6-a53a-6e85d515ca2c2025-07-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79988-002-05799880002055 mL in 1 BOTTLE (79988-002-05) 5 ml2025-01-06NoNoCurrent
79988-002-507998800025050 mL in 1 BOTTLE (79988-002-50) 50 ml2025-01-06NoNoCurrent