sunscreen

Generic: homosalate, octinoxate, octisalate, oxybenzone

Labeler: safetec of america, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sunscreen
Generic Name homosalate, octinoxate, octisalate, oxybenzone
Labeler safetec of america, inc.
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

homosalate 6 mg/g, octinoxate 7.5 mg/g, octisalate 5 mg/g, oxybenzone 5 mg/g

Manufacturer
Safetec of America, Inc.

Identifiers & Regulatory

Product NDC 61010-6103
Product ID 61010-6103_10dfe53b-4cdd-c203-e063-6294a90af360
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Listing Expiration 2026-12-31
Marketing Start 2007-03-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 610106103
Hyphenated Format 61010-6103

Supplemental Identifiers

UNII
V06SV4M95S 4Y5P7MUD51 4X49Y0596W 95OOS7VE0Y

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 sunscreen (source: ndc)
Generic Name homosalate, octinoxate, octisalate, oxybenzone (source: ndc)
Application Number M020 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/g
  • 7.5 mg/g
  • 5 mg/g
source: ndc
Packaging
  • 25 PACKET in 1 BOX (61010-6103-1) / 3.5 g in 1 PACKET (61010-6103-0)
  • 25 PACKET in 1 BOX (61010-6103-3) / 2 g in 1 PACKET (61010-6103-2)
source: ndc

Packages (2)

Ingredients (4)

homosalate (6 mg/g) octinoxate (7.5 mg/g) octisalate (5 mg/g) oxybenzone (5 mg/g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "10dfe53b-4cdd-c203-e063-6294a90af360", "openfda": {"unii": ["V06SV4M95S", "4Y5P7MUD51", "4X49Y0596W", "95OOS7VE0Y"], "spl_set_id": ["754186c8-3c88-40a0-a4e3-35e3ea9d1b4c"], "manufacturer_name": ["Safetec of America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 PACKET in 1 BOX (61010-6103-1)  / 3.5 g in 1 PACKET (61010-6103-0)", "package_ndc": "61010-6103-1", "marketing_start_date": "20070313"}, {"sample": false, "description": "25 PACKET in 1 BOX (61010-6103-3)  / 2 g in 1 PACKET (61010-6103-2)", "package_ndc": "61010-6103-3", "marketing_start_date": "20180701"}], "brand_name": "Sunscreen", "product_id": "61010-6103_10dfe53b-4cdd-c203-e063-6294a90af360", "dosage_form": "LOTION", "product_ndc": "61010-6103", "generic_name": "Homosalate, Octinoxate, Octisalate, Oxybenzone", "labeler_name": "Safetec of America, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sunscreen", "active_ingredients": [{"name": "HOMOSALATE", "strength": "6 mg/g"}, {"name": "OCTINOXATE", "strength": "7.5 mg/g"}, {"name": "OCTISALATE", "strength": "5 mg/g"}, {"name": "OXYBENZONE", "strength": "5 mg/g"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20070313", "listing_expiration_date": "20261231"}