FDA.reportPublic FDA data

Protection 50 Sport

Product NDC
68479-232
11-digit product format
684790232
Labeler code
68479
Product ID
68479-232_5d35bd2e-e627-4863-842d-0121416f91e9
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octocrylene, Octisalate, and Avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Dermalogica, LLC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-05
Substance
HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
10; 10; 5; 3 mg/100mL; mg/100mL; mg/100mL; mg/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
Protection 50 Sport
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE10 mg/100mL
OCTOCRYLENE10 mg/100mL
OCTISALATE5 mg/100mL
AVOBENZONE3 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal 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
e9ace96a-7717-4f5a-8e1b-1f56f7498599Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68479-232-00Protection 50 Sport2 mL in 1 POUCHLOTION22
68479-232-02Protection 50 Sport1 in 1 CARTONLOTION12
68479-232-02Protection 50 Sport156 mL in 1 TUBELOTION1562

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68479-232PROTECTION 50 SPORT (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) LOTION [DERMALOGICA, LLC.]2Current NDC, Legacy NDC, 3 package rows20250101_e9ace96a-7717-4f5a-8e1b-1f56f7498599.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 197 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral Sunscreen Broad Spectrum SPF 25ZINC OXIDEEarth Mama Angel Baby, LLC2aa44439-663a-400b-b432-e2dc5ac2a3d12025-08-12WarningsExact identifier
application number: M020
Tinted Mineral Sunscreen Broad Spectrum SPF 40ZINC OXIDEEarth Mama Angel Baby, LLCafc88e77-a4a1-49ec-b021-bb468fd0ac682025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD31049b45-0f5e-58b6-e063-6394a90ae52c2025-08-12WarningsExact identifier
application number: M020
Earth Mama Lady Face Mineral Sunscreen - Light/Medium Tint Broad Spectrum SPF 40ZINC OXIDEEarth Mama Angel Baby LLCbd71a814-c0b4-428b-987e-72f7f55f998f2025-08-12WarningsExact identifier
application number: M020
earth mama UBER-SENSITIVE MINERAL Sunscreen SPF 40ZINC OXIDEEarth Mama Angel Baby, LLCe9a88a57-5733-489d-a459-dd74c04daff22025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1ddae545-99db-144b-e063-6294a90adae52025-08-12WarningsExact identifier
application number: M020
Sun Bum Protecting Scalp and Hair Mist SPF 30 sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3aa05afb-c843-f38f-e063-6294a90a1cdf2025-08-12WarningsExact identifier
application number: M020
Sun Bum High Performance Sunscreen Signature Clear 50OCTOCRYLENE, OCTISALATE, ZINC OXIDESun Bum, LLC390c6afd-e2be-414c-e063-6294a90ae1192025-08-12WarningsExact identifier
application number: M020
Sun Bum 30 Premium Mosturizing Sunscreen 1 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c32d2c0-0dbe-42e3-e063-6294a90aa9932025-08-12WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c342e57-cf85-b423-e063-6394a90a61b92025-08-12WarningsExact identifier
application number: M020
MATTE UNIVERSAL TINTED MOISTURIZER SPF46ZINC OXIDE, OCTINOXATEDrmtlgy, LLC8e284afd-b90f-41d5-b334-e5cf4440b4d32025-08-12WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 22N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lad8afa83-2844-422c-b2bf-b5a61be368b12025-08-11WarningsExact identifier
application number: M020
ScarAid SPFSILICONE STICK WITH SPFBiodermis, LLC3c19063a-cdde-1bbe-e063-6294a90aa8a22025-08-11WarningsExact identifier
application number: M020
Pro-Sil SPFSILICONE STICK WITH SPFBiodermis, LLC3be06f82-935d-b1c2-e063-6294a90a953c2025-08-11WarningsExact identifier
application number: M020
Curology Daily MoisturizingAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATECurology, Inc3c1967fc-bb89-2f7e-e063-6394a90a25122025-08-11WarningsExact identifier
application number: M020
ScarAid US SPFSILICONE STICK WITH SPFBiodermis, LLC3c196fa4-1bd3-7a43-e063-6294a90a4fb72025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 23W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L96973dee-681b-4c5d-b31f-de05cd79fa182025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 24N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lecda3658-eca1-48c2-9eff-e22fd1ff70df2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 25W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc6f27df4-6de4-45e4-90cb-ea8b0d29dbd32025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 26W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L968abacd-8b99-4529-a627-2b56cdf99e1b2025-08-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68479-232-00684790232002 mL in 1 POUCH (68479-232-00) 2 ml2019-08-050000-00-00NoNoCurrent
68479-232-02684790232021 TUBE in 1 CARTON (68479-232-02) / 156 mL in 1 TUBE1 tube2019-08-050000-00-00NoNoCurrent