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 230 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil Sheer Mineral Sunscreen Stick SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.54f6df65-e90c-4070-aa95-f47496dd11bd2025-01-27WarningsExact identifier
application number: M020
Cetaphil Healthy Renew Day Cream Broad Spectrum SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEGalderma Laboratories, L.P.5b4e25ad-cd72-4960-9259-fc710bfd59da2025-01-27WarningsExact identifier
application number: M020
Well People Daygleamer Liquid Mineral Sunscreen SPF 34ZINC OXIDEe.l.f. Cosmetics, Inc.2c7621e9-0f1d-4712-e063-6294a90abd642025-01-24WarningsExact identifier
application number: M020
Equate Sunscreen SPF 30 SPORT Broad SpectrumAVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENEWal-Mart Stores Inc1697628a-91d2-45bc-bd1b-91fb38f3f8df2025-01-24WarningsExact identifier
application number: M020
DR.JART EVERY SUN DAY SUN FLUIDHOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEHave & Be Co., Ltd.f06d8f90-f3df-6d76-e053-2a95a90af1f82025-01-24WarningsExact identifier
application number: M020
CoTZ Silky Foam - TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDd63088d7-a1d7-4b56-a7d8-ad217011a8a82025-01-24WarningsExact identifier
application number: M020
CoTZ Silky Foam Non-TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD9c04b76e-ae65-4183-b475-3b8e8764db592025-01-24WarningsExact identifier
application number: M020
natural lip balm SPF15(unflavored) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.2c5a460a-dc93-14cc-e063-6294a90a0b612025-01-23WarningsExact identifier
application number: M020
360 by QUR Lemon Verbena lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb14c2-9181-5970-e053-2a95a90a41612025-01-23WarningsExact identifier
application number: M020
Soleo Organics SunscreenZINC OXIDESE Operations Pty Ltd59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b2025-01-22WarningsExact identifier
application number: M020
Neptune Ave. High Dive Barrier Repair Moisturizer Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENENeptune Ave. Inc.25034563-6420-daf6-e063-6394a90af9802025-01-22WarningsExact identifier
application number: M020
Jafra Sun body protector sunscreen broad spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b8e49dd6-305c-f717-e053-2995a90a659c2025-01-22WarningsExact identifier
application number: M020
Jafra Royal Defy Sample KitAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.c3b265b1-ab84-4ea9-b283-c92f5a4cf4612025-01-22WarningsExact identifier
application number: M020
SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODYAVOBENZONE/OCTISALATE/OCTOCRYLENEMary Kay Inc.2c4eaf2e-b034-8185-e063-6394a90a82752025-01-22WarningsExact identifier
application number: M020
Herbalife SKIN Protective Moisturizer Broad Spectrum SPF 30 Mineral SunscreenZINC OXIDEHerbalife International of America Inc.d30b7cf1-73bb-3568-e053-2995a90ad5792025-01-21WarningsExact identifier
application number: M020
Herbalife Herbal Aloe Face and Body Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEHerbalife International of America, Inc.d30d9d02-bc31-db3c-e053-2a95a90a0dab2025-01-21WarningsExact identifier
application number: M020
Sugargirl Disco Stick SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC36f30834-62be-4076-9493-f385720a1e222025-01-20WarningsExact identifier
application number: M020
Sugargirl Glowy Face Screen Shimmer Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONEI World LLC757897b0-fc65-4147-8444-2a0efdc6f81c2025-01-20WarningsExact identifier
application number: M020
Sugargirl Hot Body Screen Shimmer Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, AVOBENZONE, OCTISALATEI World LLCa9bf1342-1c4b-48ad-a955-715647df125a2025-01-20WarningsExact identifier
application number: M020
JAFRA SKIN Glow Face Cream Broad Spectrum SPF 15 SunscreenHOMOSALATE, OCTISALATE, AVOBENZONE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.Vf627ab5b-85d4-4c92-9412-4bab72828f3d2025-01-17WarningsExact 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