broad spectrum spf30 very water resistant (80 minutes) sunscreen

Generic: avobenzone, homosalate, octocrylene, octisalate

Labeler: aruba aloe balm nv
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name broad spectrum spf30 very water resistant (80 minutes) sunscreen
Generic Name avobenzone, homosalate, octocrylene, octisalate
Labeler aruba aloe balm nv
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

avobenzone 30 mg/mL, homosalate 73.4 mg/mL, octisalate 50 mg/mL, octocrylene 100 mg/mL

Manufacturer
Aruba Aloe Balm NV

Identifiers & Regulatory

Product NDC 53675-207
Product ID 53675-207_0ac055c2-6afa-8d76-e063-6294a90ab966
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Listing Expiration 2026-12-31
Marketing Start 2023-06-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53675207
Hyphenated Format 53675-207

Supplemental Identifiers

UPC
0082252020708 0082252054925 0082252054918
UNII
G63QQF2NOX V06SV4M95S 4X49Y0596W 5A68WGF6WM

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name broad spectrum spf30 very water resistant (80 minutes) sunscreen (source: ndc)
Generic Name avobenzone, homosalate, octocrylene, octisalate (source: ndc)
Application Number M020 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/mL
  • 73.4 mg/mL
  • 50 mg/mL
  • 100 mg/mL
source: ndc
Packaging
  • 30 mL in 1 TUBE (53675-207-00)
  • 59 mL in 1 TUBE (53675-207-01)
  • 177 mL in 1 TUBE (53675-207-02)
source: ndc

Packages (3)

53675-207-00 30 mL in 1 TUBE (53675-207-00) 53675-207-01 59 mL in 1 TUBE (53675-207-01) 53675-207-02 177 mL in 1 TUBE (53675-207-02)

Ingredients (4)

avobenzone (30 mg/mL) homosalate (73.4 mg/mL) octisalate (50 mg/mL) octocrylene (100 mg/mL)

Linked Drug Pages (1)

Broad Spectrum SPF30 Very Water Resistant (80 Minutes) Sunscreen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0ac055c2-6afa-8d76-e063-6294a90ab966", "openfda": {"upc": ["0082252020708", "0082252054925", "0082252054918"], "unii": ["G63QQF2NOX", "V06SV4M95S", "4X49Y0596W", "5A68WGF6WM"], "spl_set_id": ["bcd03000-f8eb-4702-987d-03ae5ee70a68"], "manufacturer_name": ["Aruba Aloe Balm NV"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 TUBE (53675-207-00)", "package_ndc": "53675-207-00", "marketing_start_date": "20230602"}, {"sample": false, "description": "59 mL in 1 TUBE (53675-207-01)", "package_ndc": "53675-207-01", "marketing_start_date": "20230602"}, {"sample": false, "description": "177 mL in 1 TUBE (53675-207-02)", "package_ndc": "53675-207-02", "marketing_start_date": "20230602"}], "brand_name": "Broad Spectrum SPF30 Very Water Resistant (80 Minutes) Sunscreen", "product_id": "53675-207_0ac055c2-6afa-8d76-e063-6294a90ab966", "dosage_form": "CREAM", "product_ndc": "53675-207", "generic_name": "AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE", "labeler_name": "Aruba Aloe Balm NV", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Broad Spectrum SPF30 Very Water Resistant (80 Minutes) Sunscreen", "active_ingredients": [{"name": "AVOBENZONE", "strength": "30 mg/mL"}, {"name": "HOMOSALATE", "strength": "73.4 mg/mL"}, {"name": "OCTISALATE", "strength": "50 mg/mL"}, {"name": "OCTOCRYLENE", "strength": "100 mg/mL"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230602", "listing_expiration_date": "20261231"}