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Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15

Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15

Approved
Approval ID

6a398dad-2fb9-4cdb-86c5-2a392b88f29b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 2025

Manufacturers
FDA

Aruba Aloe Balm NV

DUNS: 855442273

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53675-214
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (18)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALOE VERA LEAF JUICEInactive
Code: RUE8E6T4NB
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
CETETH-20 PHOSPHATEInactive
Code: 921FTA1500
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
JOJOBA OILInactive
Code: 724GKU717M
Classification: IACT
COCONUT OILInactive
Code: Q9L0O73W7L
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
MYRISTYL LAURATEInactive
Code: 58U0NZN2BT
Classification: IACT
GLYCERYL LAURATEInactive
Code: Y98611C087
Classification: IACT
MYRISTYL MYRISTATEInactive
Code: 4042ZC00DY
Classification: IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
AMINOMETHYL PROPANOLInactive
Code: LU49E6626Q
Classification: IACT
AVOBENZONEActive
Quantity: 30 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB
HOMOSALATEActive
Quantity: 73.4 mg in 1 mL
Code: V06SV4M95S
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 50 mg in 1 mL
Code: 5A68WGF6WM
Classification: ACTIB
OCTISALATEActive
Quantity: 50 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

Package Labeling:

Label0

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/11/2025

Uses

  • helps prevent sunburn.
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/11/2025

Other Information

  • protect the product in this container from excessive heat and direct sun.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/11/2025

Active ingredients

Avobenzone 3%
Homosalate 7.34%
Octocrylene 5%
Octyl Salicylate 5%

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 8/11/2025

Warnings

For external use only.

Do not use

  • on damaged or broken skin.

When using this product

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

  • rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/11/2025

Directions

  • apply generously 15 minutes before sun exposure.
  • reapply
  • after 80 minutes of swimming or sweating.
  • immediately after towel drying.
  • at least every 2 hours. ***Sun Protection Measures.**Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • children under 6 months of age: Ask a doctor.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/11/2025

Inactive ingredients

Water (Aqua/Eau), Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), VP/Eicosene Copolymer, Cetearyl Alcohol, Ceteth-20 Phosphate, Dimethicone, Tocopheryl Acetate (Vitamin E Acetate), Simmondsia Chinensis (Jojoba) Seed Oil, Cocos Nucifera (Coconut) Oil, Caprylyl Glycol, Myristyl Laurate, Glyceryl Laurate, Myristyl Myristate, Fragrance (Parfum), Glyceryl Undecylenate, Carbomer, Aminomethyl Propanol.

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Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15 - FDA Drug Approval Details