total sun protection

Generic: octinoxate, octisalate, oxybenzone, zinc oxide

Labeler: cosmed dermaceuticals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name total sun protection
Generic Name octinoxate, octisalate, oxybenzone, zinc oxide
Labeler cosmed dermaceuticals, inc.
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

octinoxate 75 mg/g, octisalate 30 mg/g, oxybenzone 30 mg/g, zinc oxide 40 mg/g

Manufacturer
Cosmed Dermaceuticals, Inc.

Identifiers & Regulatory

Product NDC 61352-004
Product ID 61352-004_43545da6-6e83-7dc3-e063-6294a90ab889
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Listing Expiration 2026-12-31
Marketing Start 2013-08-01

Pharmacologic Class

Classes
copper absorption inhibitor [epc] decreased copper ion absorption [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61352004
Hyphenated Format 61352-004

Supplemental Identifiers

UNII
4Y5P7MUD51 4X49Y0596W 95OOS7VE0Y 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 total sun protection (source: ndc)
Generic Name octinoxate, octisalate, oxybenzone, zinc oxide (source: ndc)
Application Number M020 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/g
  • 30 mg/g
  • 40 mg/g
source: ndc
Packaging
  • 127.6 g in 1 BOTTLE, PLASTIC (61352-004-01)
source: ndc

Packages (1)

61352-004-01 127.6 g in 1 BOTTLE, PLASTIC (61352-004-01)

Ingredients (4)

octinoxate (75 mg/g) octisalate (30 mg/g) oxybenzone (30 mg/g) zinc oxide (40 mg/g)

Linked Drug Pages (1)

Total Sun Protection ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "43545da6-6e83-7dc3-e063-6294a90ab889", "openfda": {"unii": ["4Y5P7MUD51", "4X49Y0596W", "95OOS7VE0Y", "SOI2LOH54Z"], "spl_set_id": ["dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f"], "manufacturer_name": ["Cosmed Dermaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "127.6 g in 1 BOTTLE, PLASTIC (61352-004-01)", "package_ndc": "61352-004-01", "marketing_start_date": "20180213"}], "brand_name": "Total Sun Protection", "product_id": "61352-004_43545da6-6e83-7dc3-e063-6294a90ab889", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "61352-004", "generic_name": "Octinoxate, Octisalate, Oxybenzone, Zinc Oxide", "labeler_name": "Cosmed Dermaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Total Sun Protection", "active_ingredients": [{"name": "OCTINOXATE", "strength": "75 mg/g"}, {"name": "OCTISALATE", "strength": "30 mg/g"}, {"name": "OXYBENZONE", "strength": "30 mg/g"}, {"name": "ZINC OXIDE", "strength": "40 mg/g"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130801", "listing_expiration_date": "20261231"}