FDA.reportPublic FDA data

First Aid Beauty Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 45

Product NDC
84126-216
11-digit product format
841260216
Labeler code
84126
Product ID
84126-216_485c264e-013e-f195-e063-6294a90ae3a8
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, and Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-01
Substance
OCTISALATE; AVOBENZONE; OCTOCRYLENE; HOMOSALATE
Active strength
5; 3; 9; 7 g/100mL; g/100mL; g/100mL; g/100mL
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
First Aid Beauty Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 45
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE5 g/100mL
AVOBENZONE3 g/100mL
OCTOCRYLENE9 g/100mL
HOMOSALATE7 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
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
485c345f-0928-fa1a-e063-6294a90aa856Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-216-50First Aid Beauty Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 451 in 1 CARTONLOTION11
84126-216-50First Aid Beauty Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 4550 mL in 1 BOTTLE, PLASTICLOTION501

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 184 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PUR 4-in-1 Skin Tint MN3ZINC OXIDEPUR Minerals3f06df49-5ed2-44ca-e063-6294a90a1fda2025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint LN2ZINC OXIDEPUR Minerals3f069dfe-289d-8d3b-e063-6394a90a04962025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint LG3ZINC OXIDEPUR Minerals3f06ec3e-fc15-9f7b-e063-6394a90a07332025-09-24WarningsExact identifier
application number: M020
Volition Prismatic Luminizing ShieldZINC OXIDEVolition1a633c24-b9d9-4732-e063-6294a90af4c02025-09-24WarningsExact identifier
application number: M020
Alleyoop Sunsational Broad SpectrumZINC OXIDENewAlley Innovations Inc248419c4-8044-402c-e063-6394a90a00f82025-09-24WarningsExact identifier
application number: M020
Aloe Up SPF 30 coco-mango mistAVOBENZONE 3.0%, HOMOSALATE 7.5%, OCTISALATE 5.0%Aloe Upf7b2d4a2-3a0d-4239-b7e5-8de2f6ac2e922025-09-24WarningsExact identifier
application number: M020
pavise Dynamic Age DefenseZINC OXIDEB.A.I BIOSCIENCES, INCf4e9f95c-6b1e-d5f7-e053-2a95a90a93ce2025-09-24WarningsExact identifier
application number: M020
Aloe Up SPF 50 coco-mango mistAVOBENZONE 3.0%, HOMOSALATE 10.0%, OCTISALATE 5.0%Aloe Upd535b711-c54e-4447-9907-ca9d829d13192025-09-24WarningsExact identifier
application number: M020
ESPOIR WATER SPLASH SUN SERUMHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEESPOIR Corporation1c4e7ba2-05e8-f949-e063-6394a90a699d2025-09-23WarningsExact identifier
application number: M020
Banana BoatZINC OXIDEEdgewell Personal Care Brands LLC1d11c3d0-5f4e-0ed0-e063-6294a90abc752025-09-23WarningsExact identifier
application number: M020
Dewscreen Daily Hydrator and Primer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop LLC3f7c84e3-0e4f-b7e9-e063-6294a90a12952025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily Gel Gel Sunscreen Moisturizer Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC15d8574d-94bb-4842-e063-6394a90a15e62025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC15da0cb1-e695-cec3-e063-6394a90a1afa2025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily Face Liquid Sunscreen Moisturizer Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC15daac41-54b6-096d-e063-6294a90a07362025-09-23WarningsExact identifier
application number: M020
Mtn. Bum by Sun Bum and Mcfetridge Mineral Sunscreen Face Stick SPF 50ZINC OXIDESun Bum, LLC3f8101b1-297d-2ad8-e063-6294a90a9cff2025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily Glow Tinted Sunscreen Moisturizer Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESun Bum, LLC20c48752-3ad9-5993-e063-6294a90ae1b02025-09-23WarningsExact identifier
application number: M020
CVS SPF 60 Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS26d1b568-ad9c-80d7-e063-6394a90a2cbf2025-09-21WarningsExact identifier
application number: M020
Radiant Shield Tinted Mineral Sunscreen SPF 40ZINC OXIDECosMedical Technologies, LLCf229b928-49fd-4e02-99c1-b2cd9166894f2025-09-19WarningsExact identifier
application number: M020
EquateDaytimeFaceLotionEQUATE DAYTIME FACE LOTION WITH SUNSCREEN, SPF 30, 3 OZWalmart Inc.2efc7087-f4ad-2f2e-e063-6394a90a13022025-09-18WarningsExact identifier
application number: M020
ERBORIAN CC RED CORRECTERBORIAN CC RED CORRECT SPF 25- OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE CREAMKolmask Co., Ld.09ca2d4b-e0c2-9961-e063-6394a90aa82e2025-09-18Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84126-216-50841260216501 BOTTLE, PLASTIC in 1 CARTON (84126-216-50) / 50 mL in 1 BOTTLE, PLASTIC2026-02-01NoNoCurrent