FDA.reportPublic FDA data

Aloe Sunscreen

Product NDC
11697-319
11-digit product format
116970319
Labeler code
11697
Product ID
11697-319_50c98089-b653-428f-bb12-5cd65b50b9a8
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octisalate, Avobenzone, Ensulizole anf Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
Aloe Vera of America, Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-08-16
Marketing end
0000-00-00
Substance
HOMOSALATE; OCTISALATE; ENSULIZOLE; AVOBENZONE; OCTOCRYLENE
Active strength
10 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11697-319-072020-01-31C16284748780-19d75b9d0-59c8-f424-e053-dadaa90a57ced1fc6718-8611-44b5-b312-8cf4866cb46b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11697-319-07Aloe Sunscreen178.000 mL in 1 BOTTLE, SPRAYSPRAY178.00013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
ENSULIZOLEACTIVE INGREDIENT9YQ9DI1W42ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
HOMOSALATEACTIVE INGREDIENTV06SV4M95SALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
OCTISALATEACTIVE INGREDIENT4X49Y0596WALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
AVOBENZONEACTIVE MOIETYG63QQF2NOXALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
ENSULIZOLEACTIVE MOIETY9YQ9DI1W42ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
HOMOSALATEACTIVE MOIETYV06SV4M95SALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
OCTISALATEACTIVE MOIETY4X49Y0596WALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D3ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
CETEARETH-25INACTIVE INGREDIENT8FA93U5T67ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
DIETHYLHEXYL CARBONATEINACTIVE INGREDIENTYCD50O0Z6LALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATEINACTIVE INGREDIENTQI9A6U005WALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
NEOPENTYL GLYCOL DIHEPTANOATEINACTIVE INGREDIENT5LKW3C543XALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
POLYESTER-7INACTIVE INGREDIENT0841698D2FALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)INACTIVE INGREDIENT5Z4DPO246AALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11697-319ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.]13Legacy NDC, 1 package rows20150130_d1fc6718-8611-44b5-b312-8cf4866cb46b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
11697-319-0711697031907178.000 mL in 1 BOTTLE, SPRAY178.000 mlHistorical