FDA.reportPublic FDA data

Olay Age Defying Classic Broad Spectrum SPF 15

Product NDC
84126-231
11-digit product format
841260231
Labeler code
84126
Product ID
84126-231_4c49d819-1466-d374-e063-6294a90af90d
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-01
Substance
OCTINOXATE; ZINC OXIDE
Active strength
6; 3 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
Olay Age Defying Classic Broad Spectrum SPF 15
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE6 g/100mL
ZINC OXIDE3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4c49dbf1-d1fe-ad4a-e063-6394a90af151Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-231-12Olay Age Defying Classic Broad Spectrum SPF 151 in 1 CARTONLOTION16
84126-231-12Olay Age Defying Classic Broad Spectrum SPF 15120 mL in 1 BOTTLE, PLASTICLOTION1206

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 332 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRIDEFUL SPF 15 LIP BALM-passion fruitHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCd6b6389b-c8bd-4aca-8ccf-455dbc22070d2023-10-26WarningsExact identifier
application number: M020
PRIDEFUL SPF 15 LIP BALM-coconutHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCa6af5cdc-999d-45ba-a7a6-5e7330f8b9c02023-10-26WarningsExact identifier
application number: M020
PRIDEFUL SPF 15 LIP BALM-melonHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCe201fec6-eb69-40fb-8459-02d64e34a3b72023-10-26WarningsExact identifier
application number: M020
PRIDEFUL SPF 15 LIP BALM-orange mangoHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCc50c9f00-6a0f-4307-b35d-7fc5fa3b7edf2023-10-26WarningsExact identifier
application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLCe5fcb1fd-ad61-1ea5-e053-2a95a90a24722023-10-26WarningsExact identifier
application number: M020
Grape Soda SPF 15 Broad Spectrum Lip BalmGRAPE SODA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca09a0b5f-93e4-d18a-e053-2a95a90a65f72023-10-26WarningsExact identifier
application number: M020
Beeswax SPF 30 Broad Spectrum Lip BalmBEESWAX SPF 30 BROAD SPECTRUM LIP BALMRaining Rose, Inca962bfca-03a3-8dde-e053-2a95a90abbb92023-10-26WarningsExact identifier
application number: M020
CreamZINC OXIDEOxygen Development LLC08a1e862-b55a-fb84-e063-6294a90a016a2023-10-26WarningsExact identifier
application number: M020
SIMPLE TRUTH MINERAL BASED SPF 50 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDETHE KROGER COMPANYa52872bf-cd0f-06da-e053-2995a90af28d2023-10-26WarningsExact identifier
application number: M020
Babo Botanicals Sensitive Baby Mineral Sunscreen SPF30ZINC OXIDEBabo Botanicals, Inc.08a36887-3997-8fff-e063-6394a90ae9d52023-10-26WarningsExact identifier
application number: M020
PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45TITANIUM DIOXIDE AND ZINC OXIDEESTEE LAUDER INCe87c4a76-5f21-4989-a1e0-0b7c6902f2012023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Unflavored Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN UNFLAVORED LIP BALMRaining Roseefe20472-aa84-1cb4-e053-2a95a90abfd82023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Mint Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN MINT LIP BALMRaining Roseefe1113b-6101-0c15-e053-2a95a90a02a72023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Tropical Smoothie Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN TROPICAL SMOOTHIE LIP BALMRaining Roseefe176f7-9c11-106e-e053-2a95a90a9c882023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Citrus Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN CITRUS LIP BALMRaining Roseefdfc182-3ac0-1a3d-e053-2a95a90a894e2023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Iced Pear Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN ICED PEAR LIP BALMRaining Roseefe01abd-0ee2-6bd6-e053-2a95a90a123d2023-10-26WarningsExact identifier
application number: M020
Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40TITANIUM DIOXIDE, ZINC OXIDENATURA BISSE INTERNATIONAL SAbf8b71c7-257b-0eb6-e053-2a95a90a3a4c2023-10-26WarningsExact identifier
application number: M020
Carmex Weather Guard Moisturizing Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMCarma Laboratories, Inc.843677f2-78fa-4f3d-9fe6-e45e35b728e32023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Cupcake Batter SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baec9be7-5ae6-135c-e053-2995a90a2ed42023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Fresh Cherry SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baea3596-6eb0-4d98-e053-2995a90a75cc2023-10-25WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84126-231-12841260231121 BOTTLE, PLASTIC in 1 CARTON (84126-231-12) / 120 mL in 1 BOTTLE, PLASTIC2025-09-01NoNoCurrent