Sunscreen for baby SPF50plus

Product NDC
84509-105
11-digit product format
845090105
Labeler code
84509
Product ID
84509-105_4e784b54-ce43-c667-e063-6394a90a8679
Type
HUMAN OTC DRUG
Nonproprietary name
Octocrylene,Ethylhexyl Methoxycinnamate,Titanium Dioxide,Ethylhexyl Salicylate
Dosage form
LOTION
Route
TOPICAL
Labeler
Guangzhou Senmai Biotechnology Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-02
Substance
OCTOCRYLENE; TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE
Active strength
3000; 2400; 3000; 1500 mg/30mL; mg/30mL; mg/30mL; mg/30mL
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
Sunscreen for baby SPF50plus
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE3000 mg/30mL
TITANIUM DIOXIDE2400 mg/30mL
OCTINOXATE3000 mg/30mL
OCTISALATE1500 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
15FIX9V2JPInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1cb7fbca-0874-ae53-e063-6294a90ab42aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84509-105-01Sunscreen for baby SPF50plus30 mL in 1 BOTTLELOTION307

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 67 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hampton Sun SPF 30 MineralZINC OXIDE 7.20% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCb8ee428e-07d3-4c6c-853c-cfbe3e4002d92026-01-28WarningsExact identifier
application number: M020
SHISEIDO FUTURE LX UNIVERSAL DEFENSE SOCTISALATE, OCTOCRYLENE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION0a6f8eef-48e9-44f5-9811-629bc0dc07d02026-01-28WarningsExact identifier
application number: M020
Hampton Sun SPF 45 Tinted FaceHOMOSALATE 10% OCTOCRYLENE 6% AVOBENZONE 3%S&C Hampton Sun LLC0fc0f2c7-ec0f-4976-9872-82a6bfe8b46b2026-01-28WarningsExact identifier
application number: M020
Walgreens 70 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY49775d1a-e573-a596-e063-6294a90a7cf62026-01-28WarningsExact identifier
application number: M020
AVON ANEW ULTIMATE MULTI-PERFORMANCE DAY BROAD SPECTRUM SPF 25 SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE, OXYBENZONEThe Avon Company49784430-2ffe-0cbb-e063-6394a90adb232026-01-28WarningsExact identifier
application number: M020
ALOE UP SPORT SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC3f2f90f1-28dd-48e8-9083-ea04815acc6b2026-01-28WarningsExact identifier
application number: M020
ALOE UP PRO 30 CONTINUOUS SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLCbaf32d84-4db5-4ed0-9814-5470b7d1f4a42026-01-28WarningsExact identifier
application number: M020
ALOE UP PRO 15AVOBENZONE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC5b0f43fc-f4a6-4403-a40e-e0198a6f2ebd2026-01-28WarningsExact identifier
application number: M020
ALOE UP PRO 50 CONTINUOUS SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLCdc33d9e8-3463-485d-a1ee-6319ed91454c2026-01-28WarningsExact identifier
application number: M020
ALOE ICE SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLCe4b861d2-3680-4ed7-8650-d1d839da5ab22026-01-28WarningsExact identifier
application number: M020
ALOE UP SPORT SPF-15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC1bf1635a-825e-417f-97b4-4bce6d251d192026-01-28WarningsExact identifier
application number: M020
Mineral SunscreenZINC OXIDE 20%The Daily Suncare LLC, DBA Daily Shade1a392f6b-1bb1-c49d-e063-6294a90a791d2026-01-28WarningsExact identifier
application number: M020
KIZO LAB UV DEFENSE CLEAR SUNSCREN SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEYB CHEMIA LLC0053ae49-b9a1-c3f4-e063-6394a90abcb82026-01-28WarningsExact identifier
application number: M020
Orange GelAVOBENZONE OCTISALATE OCTOCRYLENE HOMOSALATEVacation Inc.132896ef-d6c6-4ec7-e063-6294a90a103b2026-01-28WarningsExact identifier
application number: M020
REDEFINE Triple DefenseAVOBENZONE, OCTISALATE, OCTOCRYLENERodan & Fieldsd1dd62c6-33ac-4941-ab99-9eb8cc3c208a2026-01-27WarningsExact identifier
application number: M020
Centellian24 Madeca Derma Shield Vital Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE7054144e11009-ffcb-dd59-e063-6294a90add222026-01-27WarningsExact identifier
application number: M020
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M020
ONSART Mineral Sunscreen SPF 50ZINC OXIDE 24%Guangzhou Huixue Biotechnology Co., Ltd.495e3266-a59f-42f7-e063-6394a90adfa32026-01-27WarningsExact identifier
application number: M020
Poolside Sun Daze Body Illuminator SPF 30 Shimmer SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC54868d6f-ae4c-476d-8c77-c4a72b13d2ea2026-01-27WarningsExact identifier
application number: M020
Sugargirl Set SPF 30 Sunscreen Shimmer Sunscreen Mist For the FaceHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCdd036e0c-0c27-42b3-9d2c-33839a8631f92026-01-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84509-105-018450901050130 mL in 1 BOTTLE (84509-105-01) 30 ml2026-04-02NoNoCurrent