os-01 lip spf bs spf15

Generic: zinc oxide

Labeler: oneskin inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name os-01 lip spf bs spf15
Generic Name zinc oxide
Labeler oneskin inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

zinc oxide 5.5 g/100g

Manufacturer
ONESKIN INC.

Identifiers & Regulatory

Product NDC 84451-004
Product ID 84451-004_351d69f9-5ae2-1dec-e063-6294a90ad7a1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Listing Expiration 2026-12-31
Marketing Start 2025-05-07

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84451004
Hyphenated Format 84451-004

Supplemental Identifiers

UNII
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 os-01 lip spf bs spf15 (source: ndc)
Generic Name zinc oxide (source: ndc)
Application Number M020 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5.5 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (84451-004-02) / 12 g in 1 TUBE (84451-004-01)
source: ndc

Packages (1)

Ingredients (1)

zinc oxide (5.5 g/100g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "351d69f9-5ae2-1dec-e063-6294a90ad7a1", "openfda": {"unii": ["SOI2LOH54Z"], "spl_set_id": ["351d55f6-fcd9-1d47-e063-6294a90a2cf0"], "manufacturer_name": ["ONESKIN INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (84451-004-02)  / 12 g in 1 TUBE (84451-004-01)", "package_ndc": "84451-004-02", "marketing_start_date": "20250507"}], "brand_name": "OS-01 Lip SPF BS SPF15", "product_id": "84451-004_351d69f9-5ae2-1dec-e063-6294a90ad7a1", "dosage_form": "CREAM", "product_ndc": "84451-004", "generic_name": "Zinc Oxide", "labeler_name": "ONESKIN INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "OS-01 Lip SPF BS SPF15", "active_ingredients": [{"name": "ZINC OXIDE", "strength": "5.5 g/100g"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250507", "listing_expiration_date": "20261231"}