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 275 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health Sport SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf799bad7-b3df-f9a5-e053-6294a90ab1042024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf41e145c-896e-2782-e053-2995a90a5f812024-10-17WarningsExact identifier
application number: M020
CVS Health AM Moisturizing Facial Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTOCRYLENE, ZINC OXIDECVS PHARMACYf9c89108-1568-ee3e-e053-6294a90ac7562024-10-17WarningsExact identifier
application number: M020
CVS Health 50 Clear Zinc Broad Spectrum SPF 50 SunscreenOCTOCRYLENE, ZINC OXIDECVS PHARMACYfa19e9d3-6ab8-cbd6-e053-6294a90aae9b2024-10-17WarningsExact identifier
application number: M020
CVS Health Sport 30 ClearAVOBENZONE, HOMOSALATE, OCTOCRYLENECVS PHARMACYfbe6ae15-28ef-2acf-e053-6394a90a8d422024-10-17WarningsExact identifier
application number: M020
CVS Health 45 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyfc4addf0-9a6e-292f-e053-6294a90ab9c02024-10-17WarningsExact identifier
application number: M020
CVS Health Sport 70AVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYfc4a79ce-208e-2aed-e053-6394a90a06bb2024-10-17WarningsExact identifier
application number: M020
CVS Health Sport 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENECVS PHARMACYfc4bbb80-c3f6-c4f7-e053-6394a90a4cae2024-10-17WarningsExact identifier
application number: M020
SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEMOULAS SUPER MARKETS, INCee782436-9eff-49e4-8edc-fd9783454c072024-10-17WarningsExact identifier
application number: M020
GLOW RECIPE WATERMELON GLOW DEW BALM SPF 45AVOBENZONE, HOMOSALATE, OCTISALATEAramara Beauty LLC dba Glow Recipe0c437f88-c731-5834-e063-6394a90a32992024-10-17WarningsExact identifier
application number: M020
SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEMOULAS SUPER MARKETS, INC5ce3e436-37d1-4918-bb14-0be33b0bc86a2024-10-17WarningsExact identifier
application number: M020
MARKET BASKET KIDS SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEMOULAS SUPER MARKETS, INC.a6a381da-6e34-bffe-e053-2a95a90a46f22024-10-17WarningsExact identifier
application number: M020
Market Basket Continuous Sunscreen SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEDEMOULAS SUPER MARKETS, INC.f4238107-c76c-266a-e053-2a95a90a89782024-10-17WarningsExact identifier
application number: M020
Market Basket Continuous Sunscreen General Protection SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEDEMOULAS SUPER MARKETS, INC.e7182d07-a006-db4b-e053-2995a90aa9e12024-10-17WarningsExact identifier
application number: M020
EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEArmy & Air Force Exchange Servicee467df80-9007-46c9-e053-2a95a90a1bef2024-10-17WarningsExact identifier
application number: M020
EXCHANGE SELECT KIDS SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEArmy & Air Force Exchange Servicee467c306-a2ed-4976-e053-2995a90a56ed2024-10-17WarningsExact identifier
application number: M020
Exchange Select Sport Sunscreen Continuous SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEArmy & Air Force Exchange Servicee716ba8c-0148-07f2-e053-2a95a90a53df2024-10-17WarningsExact identifier
application number: M020
EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEArmy & Air Force Exchange Servicef55828b4-f2a4-13ec-e053-2995a90a0f842024-10-17WarningsExact identifier
application number: M020
SPF50 Plus Mineral SunscreenZINC OXIDE AND TITANIUM DIOXIDEKAS Direct LLC dba BabyGanics08e8bc10-85d8-4215-8351-7ec12029416c2024-10-17WarningsExact identifier
application number: M020
bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural Citrus ScentOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEBu Brands, LLC9ac92c96-5bcf-421d-9cd0-73ddfa10195c2024-10-17WarningsExact 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