softlips vanilla

Generic: dimethicone, octinoxate, octisalate, oxybenzone

Labeler: the mentholatum company
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name softlips vanilla
Generic Name dimethicone, octinoxate, octisalate, oxybenzone
Labeler the mentholatum company
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

dimethicone 20 mg/g, octinoxate 75 mg/g, octisalate 30 mg/g, oxybenzone 30 mg/g

Manufacturer
The Mentholatum Company

Identifiers & Regulatory

Product NDC 10742-3051
Product ID 10742-3051_43fde22f-2a7f-7b72-e063-6294a90a3254
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Listing Expiration 2026-12-31
Marketing Start 1997-11-19

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 107423051
Hyphenated Format 10742-3051

Supplemental Identifiers

UPC
0310742012187
UNII
92RU3N3Y1O 4Y5P7MUD51 4X49Y0596W 95OOS7VE0Y
NUI
N0000010282

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 softlips vanilla (source: ndc)
Generic Name dimethicone, octinoxate, octisalate, oxybenzone (source: ndc)
Application Number M020 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
  • 75 mg/g
  • 30 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 BLISTER PACK (10742-3051-1) / 2 g in 1 TUBE
  • 2 g in 1 TUBE (10742-3051-2)
  • 3 TUBE in 1 BLISTER PACK (10742-3051-3) / 2 g in 1 TUBE
  • 2 TUBE in 1 BLISTER PACK (10742-3051-9) / 2 g in 1 TUBE
source: ndc

Packages (4)

10742-3051-1 1 TUBE in 1 BLISTER PACK (10742-3051-1) / 2 g in 1 TUBE 10742-3051-2 2 g in 1 TUBE (10742-3051-2) 10742-3051-3 3 TUBE in 1 BLISTER PACK (10742-3051-3) / 2 g in 1 TUBE 10742-3051-9 2 TUBE in 1 BLISTER PACK (10742-3051-9) / 2 g in 1 TUBE

Ingredients (4)

dimethicone (20 mg/g) octinoxate (75 mg/g) octisalate (30 mg/g) oxybenzone (30 mg/g)

Linked Drug Pages (1)

Softlips Vanilla ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "43fde22f-2a7f-7b72-e063-6294a90a3254", "openfda": {"nui": ["N0000010282"], "upc": ["0310742012187"], "unii": ["92RU3N3Y1O", "4Y5P7MUD51", "4X49Y0596W", "95OOS7VE0Y"], "spl_set_id": ["8dff782f-7201-4ad9-94d2-672058f817b8"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["The Mentholatum Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BLISTER PACK (10742-3051-1)  / 2 g in 1 TUBE", "package_ndc": "10742-3051-1", "marketing_start_date": "19971119"}, {"sample": false, "description": "2 g in 1 TUBE (10742-3051-2)", "package_ndc": "10742-3051-2", "marketing_start_date": "19971119"}, {"sample": false, "description": "3 TUBE in 1 BLISTER PACK (10742-3051-3)  / 2 g in 1 TUBE", "package_ndc": "10742-3051-3", "marketing_start_date": "20200302"}, {"sample": false, "description": "2 TUBE in 1 BLISTER PACK (10742-3051-9)  / 2 g in 1 TUBE", "package_ndc": "10742-3051-9", "marketing_start_date": "19971119"}], "brand_name": "Softlips Vanilla", "product_id": "10742-3051_43fde22f-2a7f-7b72-e063-6294a90a3254", "dosage_form": "OINTMENT", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "10742-3051", "generic_name": "dimethicone, octinoxate, octisalate, oxybenzone", "labeler_name": "The Mentholatum Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Softlips", "brand_name_suffix": "Vanilla", "active_ingredients": [{"name": "DIMETHICONE", "strength": "20 mg/g"}, {"name": "OCTINOXATE", "strength": "75 mg/g"}, {"name": "OCTISALATE", "strength": "30 mg/g"}, {"name": "OXYBENZONE", "strength": "30 mg/g"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19971119", "listing_expiration_date": "20261231"}