FDA.reportPublic FDA data

Aruba Aloe Very Water Resistant Sunscreen

Product NDC
53675-155
Requested package NDC
53675-155-06
11-digit product format
536750155
Labeler code
53675
Product ID
53675-155_7c736d84-e1fa-3176-e053-2a91aa0a2c42
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OXYBENZONE
Dosage form
LOTION
Route
TOPICAL
Labeler
Aruba Aloe Balm, NV
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-07-08
Marketing end
0000-00-00
Substance
OXYBENZONE; OCTINOXATE
Active strength
45 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53675-15553675-155-06DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53675-155-02Aruba Aloe Very Water Resistant Sunscreen SPF 1565 mL in 1 BOTTLELOTION653
53675-155-06Aruba Aloe Very Water Resistant Sunscreen SPF 15177 mL in 1 BOTTLELOTION1773

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51ARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51ARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
ACETATE IONINACTIVE INGREDIENT569DQM74SCARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208ARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
CETYL PHOSPHATEINACTIVE INGREDIENTVT07D6X67OARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39ARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
MYRISTYL MYRISTATEINACTIVE INGREDIENT4042ZC00DYARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1
WATERINACTIVE INGREDIENT059QF0KO0RARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53675-155ARUBA ALOE VERY WATER RESISTANT SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [ARUBA ALOE BALM, NV]3Legacy NDC, 2 package rows20231108_1789ff33-7973-45dd-a159-3156191d9d8c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53675-155-0653675015506177 mL in 1 BOTTLE (53675-155-06) 177 ml2011-07-080000-00-00NoNoCurrent