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 97 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Every Tone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incf3e3f4c6-2cb9-7b17-e053-2a95a90a38542025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Age Defense Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23f88c88-b68e-4706-e063-6294a90afb382025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incd473113d-2fc3-6b1c-e053-2a95a90a88ed2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6%Beiersdorf Incd89df7a5-7741-3e1d-e053-2995a90ae2752025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd475e14f-dab1-dec5-e053-2995a90aef732025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd4757d99-bac6-48fb-e053-2a95a90ab1bf2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc24d3fbbc-0bce-b47a-e063-6394a90a9afa2025-12-31WarningsExact identifier
application number: M020
Sei Bella CC Brightening Creme LightOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.6894b9d9-a5b5-4c98-e053-2991aa0a9ca22025-12-31WarningsExact identifier
application number: M020
Sei Bella CC Brightening Creme FairOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.6892952a-d032-30bf-e053-2a91aa0a3bba2025-12-31WarningsExact identifier
application number: M020
Sei Bella CC Brightening Creme Medium TanOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.68a4e8b4-36cb-6306-e053-2a91aa0a6d252025-12-31WarningsExact identifier
application number: M020
Sei Bella CC Brightening Creme MediumOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.68a4ed34-f492-67a6-e053-2a91aa0a04282025-12-31WarningsExact identifier
application number: M020
Sei Bella Daily UV Defense Broad-Spectrum SPF 25 SunscreenSUNSCREENMelaleuca Inc.1f1d1575-cf37-5d66-e063-6394a90ab2a32025-12-31WarningsExact identifier
application number: M020
Eucerin Daily HydrationAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Incc9bb7d33-783b-4cbb-a130-91f92d4cc1372025-12-31WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Creme Sheer to Light 140 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.a13e5326-73c3-9fa8-e053-2a95a90aae9d2025-12-31WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Creme Sheer to Light 20 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.a13e3f45-8e6f-6a3f-e053-2995a90a17d22025-12-31WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Creme Deep 550 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e31a82-0cd0-5a1a-e053-2991aa0a33f82025-12-31WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Creme Light to Medium 200 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e2dfaa-d173-e6a9-e053-2a91aa0a46632025-12-31WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Creme Medium 300 WTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e2e541-c583-0f12-e053-2991aa0a4ab22025-12-31WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 500 WTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e30231-4fba-35d4-e053-2991aa0a33cb2025-12-31WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Creme Medium 440 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e30255-5640-3b4a-e053-2991aa0ab3f72025-12-31WarningsExact 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