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#

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 279 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Dry Oil Tanning Sunscreen Broad Spectrum SPF 15 Reef FriendlyAVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONETHE KROGER COMPANYc706aaf0-a978-7848-e053-2995a90a0aca2024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Ultimate Sheer Sun Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONETOPCO ASSOCIATES LLCc51029f4-ede0-08ef-e053-2995a90aecaf2024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE,TOPCO ASSOCIATES LLCc8af028e-9d68-4023-e053-2995a90ad18a2024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY ULTRA PROTECTION SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCc5601d22-2353-7319-e053-2a95a90a16c02024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCc8c12a5a-59f5-6515-e053-2995a90a58f72024-10-15WarningsExact identifier
application number: M020
Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCc6268778-8dcc-24b6-e053-2995a90acf032024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Sport Sun SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENETOPCO ASSOCIATES LLCf0de2999-f12b-89b1-e053-2a95a90ac6102024-10-15WarningsExact identifier
application number: M020
TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN ZINC OXIDE SPF 50ZINC OXIDETOPCO ASSOCIATES LLCd501a94e-3bcd-d8e4-e053-2a95a90a33b02024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Kids Mineral SunscreenZINC OXIDETOPCO ASSOCIATES LLCdbee42c8-9cae-7a81-e053-2a95a90a23292024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Sport Sun Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCf12c09b1-8ffe-4933-e053-2995a90a434f2024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Mineral Sunscreen Zinc Oxide SPF 30ZINC OXIDETOPCO ASSOCIATES LLCdbf03882-ab1a-9805-e053-2995a90a71092024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Mineral Sunscreen Continuous Broad Spectrum SPF 50 Reef-Conscious FormulaTITANIUM DIOXIDE, ZINC OXIDETOPCO ASSOCIATES LLCf14f43e6-ee57-5495-e053-2a95a90a40112024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Sport Continuous Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONETOPCO ASSOCIATES LLCf31ea60e-1f52-c55f-e053-2a95a90afe642024-10-15WarningsExact identifier
application number: M020
Topco Topcare Everyday Mineral Sunscreen Continuous SPF 30ZINC OXIDETOPCO ASSOCIATES LLCf71e019b-392a-f8eb-e053-6394a90a871e2024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY SPORT SPF 70 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONETOPCO ASSOCIATES LLCa5b06600-f2b0-6d9b-e053-2995a90a59f02024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Ultra Protection Sun SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCf41d4c46-7998-afe6-e053-2995a90ab3612024-10-15WarningsExact identifier
application number: M020
TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50OCTISALATE, ZINC OXIDETOPCO ASSOCIATES LLCf71c9060-3daf-e1be-e053-6294a90a4f912024-10-15WarningsExact identifier
application number: M020
MINERAL SUNSCREEN SPF 50ZINC OXIDE, TITANIUM DIOXIDETOPCO ASSOCIATES LLCbfe076fa-f21f-2c46-e053-2a95a90acee42024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Mineral Sunscreen StickZINC OXIDEH.E.B.f58f0199-bf22-2197-e053-2995a90ae64f2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry ScentedZINC OXIDEH.E.B.f58d328c-8b30-b4d4-e053-2a95a90adb592024-10-15WarningsExact 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