FDA.reportPublic FDA data

ALOE UP PRO 15

Product NDC
61477-207
11-digit product format
614770207
Labeler code
61477
Product ID
61477-207_497ac89a-347e-07c8-e063-6394a90a4f51
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTISALATE, OCTOCRYLENE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Aloe Care International, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-24
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
2; 5; 1.85 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61477-207-1686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61477-207-16bd6a592717d7…303034d00443…

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
ALOE UP PRO 15
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2 g/100mL
OCTISALATE5 g/100mL
OCTOCRYLENE1.85 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5b0f43fc-f4a6-4403-a40e-e0198a6f2ebdAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-02-13ALOE UP - PRO SPF 15 SPRAY (61477-207)
2023-07-28ALOE UP - PRO SPF 15 SPRAY (61477-207)
2022-04-14ALOE UP - PRO SPF 15 SPRAY (61477-207)
2022-01-28ALOE UP - PRO SPF 15 SPRAY (61477-207)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61477-207-16ALOE UP PRO 15177 mL in 1 BOTTLE, SPRAYSPRAY17710

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]3
OCTISALATEACTIVE INGREDIENT4X49Y0596WALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]3
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]3
AVOBENZONEACTIVE MOIETYG63QQF2NOXALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]3
OCTISALATEACTIVE MOIETY4X49Y0596WALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]3
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]3
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]3
DIBUTYL MALEATEINACTIVE INGREDIENT4X371TMK9KALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]3
DIETHYLHEXYL 2,6-NAPHTHALATEINACTIVE INGREDIENTI0DQJ7YGXMALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]3
ISOBORNYL METHACRYLATEINACTIVE INGREDIENT33GSY5DKCQALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]3
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)INACTIVE INGREDIENTT9296U138PALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61477-207ALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]9Current NDC, Legacy NDC, 1 package rows20240214_5b0f43fc-f4a6-4403-a40e-e0198a6f2ebd.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 95 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Kids Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incc068a6e7-260f-0766-e053-2995a90a422f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Suncreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inccc43f433-51ff-ed6a-e053-2a95a90ad3c52025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Mineral Sunscreen SPF 50ZINC OXIDEBeiersdorf Incb5bb6eb6-3356-e2a5-e053-2995a90aa6842025-12-31WarningsExact identifier
application number: M020
Coppertone Limited Edition Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incccbf7795-e153-1a43-e053-2a95a90ad4b62025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd9cbdb4-42f1-3063-e053-2a95a90a08aa2025-12-31WarningsExact identifier
application number: M020
Eucerin Baby Sensitive Mineral SPF 50 SunscreenZINC OXIDEBeiersdorf Inccdb19c82-9845-eabc-e053-2a95a90a31f72025-12-31WarningsExact identifier
application number: M020
Eucerin Advance Hydration Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd61e4d7-776d-8d84-e053-2995a90a48192025-12-31WarningsExact identifier
application number: M020
Eucerin Oil-Control SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccda04484-ba84-2276-e053-2a95a90a41c82025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc240dd76a-8f39-caec-e063-6294a90abbbc2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan SPF 30AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3994886-2ebe-a9d2-e053-2995a90aaf9a2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3d471b8-7430-98b0-e053-2995a90aba4b2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc241f78be-0d7f-c5ca-e063-6294a90a997a2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdort Incd39a009d-1f33-88bb-e053-2a95a90a03a02025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd460d669-42df-46c0-e053-2a95a90ad77b2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 8AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd370094c-3373-594b-e053-2a95a90a114a2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15(TO DELIVER) AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inc0a5a35be-9e24-18dd-e063-6394a90a097f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd462081f-f082-5df2-e053-2995a90aa1d92025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3e66496-bc3c-d189-e053-2a95a90a06b62025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc.c05388dc-4282-ee79-e053-2a95a90a376a2025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incb60dcbd1-42d0-646f-e053-2a95a90a497d2025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61477-207-1661477020716177 mL in 1 BOTTLE, SPRAY (61477-207-16) 177 ml2014-02-240000-00-00NoNoCurrent