homosalate, octisalate, zinc oxide

Generic: homosalate, octisalate, zinc oxide

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name homosalate, octisalate, zinc oxide
Generic Name homosalate, octisalate, zinc oxide
Labeler topco associates llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

homosalate 100 mg/mL, octisalate 50 mg/mL, zinc oxide 63 mg/mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-957
Product ID 76162-957_4ab9f7f0-adbb-d8a3-e063-6394a90ad8d0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Listing Expiration 2027-12-31
Marketing Start 2026-01-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162957
Hyphenated Format 76162-957

Supplemental Identifiers

UNII
V06SV4M95S 4X49Y0596W SOI2LOH54Z

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 homosalate, octisalate, zinc oxide (source: ndc)
Generic Name homosalate, octisalate, zinc oxide (source: ndc)
Application Number M020 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
  • 50 mg/mL
  • 63 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (76162-957-21) / 89 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

76162-957-21 1 BOTTLE, PLASTIC in 1 CARTON (76162-957-21) / 89 mL in 1 BOTTLE, PLASTIC

Ingredients (3)

homosalate (100 mg/mL) octisalate (50 mg/mL) zinc oxide (63 mg/mL)

Linked Drug Pages (1)

Homosalate, Octisalate, Zinc oxide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4ab9f7f0-adbb-d8a3-e063-6394a90ad8d0", "openfda": {"unii": ["V06SV4M95S", "4X49Y0596W", "SOI2LOH54Z"], "spl_set_id": ["48fb9a3c-c058-ce71-e063-6294a90aaf1e"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (76162-957-21)  / 89 mL in 1 BOTTLE, PLASTIC", "package_ndc": "76162-957-21", "marketing_start_date": "20260122"}], "brand_name": "Homosalate, Octisalate, Zinc oxide", "product_id": "76162-957_4ab9f7f0-adbb-d8a3-e063-6394a90ad8d0", "dosage_form": "LOTION", "product_ndc": "76162-957", "generic_name": "Homosalate, Octisalate, Zinc oxide", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Homosalate, Octisalate, Zinc oxide", "active_ingredients": [{"name": "HOMOSALATE", "strength": "100 mg/mL"}, {"name": "OCTISALATE", "strength": "50 mg/mL"}, {"name": "ZINC OXIDE", "strength": "63 mg/mL"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20260122", "listing_expiration_date": "20271231"}