la roche posay laboratoire dermatologique cicaplast balm b5 uv skin protectant sunscreen soothing therapeutic multi-purpose broad spectrum spf 50 (82046-992)

Drug Facts

Product Profile

Brand Name la roche posay laboratoire dermatologique cicaplast balm b5 uv skin protectant sunscreen soothing therapeutic multi-purpose broad spectrum spf 50

Generic Name dimethicone, homosalate, octisalate, octocrylene and zinc oxide

Labeler loreal usa products inc

Dosage Form CREAM

Routes

TOPICAL

Active Ingredients

dimethicone 10 mg/mL, homosalate 80 mg/mL, octisalate 50 mg/mL, octocrylene 50 mg/mL, zinc oxide 70 mg/mL

Manufacturer

LOreal USA Products Inc

Identifiers & Regulatory

Product NDC 82046-992

Product ID 82046-992_c2da8eea-af3e-4971-82eb-1597bf12a816

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M020

Listing Expiration 2026-12-31

Marketing Start 2024-04-01

Pharmacologic Class

Physiologic Effect

skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82046992

Hyphenated Format 82046-992

Supplemental Identifiers

UNII

92RU3N3Y1O V06SV4M95S 4X49Y0596W 5A68WGF6WM SOI2LOH54Z

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 la roche posay laboratoire dermatologique cicaplast balm b5 uv skin protectant sunscreen soothing therapeutic multi-purpose broad spectrum spf 50 (source: ndc)

Generic Name dimethicone, homosalate, octisalate, octocrylene and zinc oxide (source: ndc)

Application Number M020 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

10 mg/mL
80 mg/mL
50 mg/mL
70 mg/mL

source: ndc

Packaging

1 TUBE in 1 CARTON (82046-992-01) / 40 mL in 1 TUBE

source: ndc

Packages (1)

82046-992-01 1 TUBE in 1 CARTON (82046-992-01) / 40 mL in 1 TUBE

Ingredients (5)

dimethicone (10 mg/mL) homosalate (80 mg/mL) octisalate (50 mg/mL) octocrylene (50 mg/mL) zinc oxide (70 mg/mL)

Linked Drug Pages (1)

LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "c2da8eea-af3e-4971-82eb-1597bf12a816", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O", "V06SV4M95S", "4X49Y0596W", "5A68WGF6WM", "SOI2LOH54Z"], "spl_set_id": ["92a1d6ce-aff3-45fc-8d98-20c4375aded8"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["LOreal USA Products Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (82046-992-01)  / 40 mL in 1 TUBE", "package_ndc": "82046-992-01", "marketing_start_date": "20240401"}], "brand_name": "LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50", "product_id": "82046-992_c2da8eea-af3e-4971-82eb-1597bf12a816", "dosage_form": "CREAM", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "82046-992", "generic_name": "Dimethicone, Homosalate, Octisalate, Octocrylene and Zinc oxide", "labeler_name": "LOreal USA Products Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50", "active_ingredients": [{"name": "DIMETHICONE", "strength": "10 mg/mL"}, {"name": "HOMOSALATE", "strength": "80 mg/mL"}, {"name": "OCTISALATE", "strength": "50 mg/mL"}, {"name": "OCTOCRYLENE", "strength": "50 mg/mL"}, {"name": "ZINC OXIDE", "strength": "70 mg/mL"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240401", "listing_expiration_date": "20261231"}