Home NDC 82046-992 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50
Product NDC 82046-992
11-digit product format 820460992
Labeler code 82046
Product ID 82046-992_dbe82016-deec-4bed-a41d-11f1a873728f
Type HUMAN OTC DRUG
Nonproprietary name Dimethicone, Homosalate, Octisalate, Octocrylene and Zinc oxide
Dosage form CREAM
Route TOPICAL
Labeler L�Oreal USA Products Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-01
Substance HOMOSALATE; OCTISALATE; DIMETHICONE; OCTOCRYLENE; ZINC OXIDE
Active strength 80; 50; 10; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 80 mg/mL OCTISALATE 50 mg/mL DIMETHICONE 10 mg/mL OCTOCRYLENE 50 mg/mL ZINC OXIDE 70 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82046-992-01 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50 40 mL in 1 TUBE CREAM 40 2 82046-992-01 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50 1 in 1 CARTON CREAM 1 2 82046-992-02 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50 5 mL in 1 TUBE CREAM 5 2 82046-992-02 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50 15 in 1 CARTON CREAM 15 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 240 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join sunbetter Broad Spectrum SPF 70 Sunscreen Sheer ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC b879067b-9d7f-3a62-e053-2995a90a9d6b 2025-01-06 Warnings Exact identifier application number: M020 Bondi Sands SPF 60 Sunny Kiss Lip Balm Coconut Crush AVOBENZONE, HOMOSALATE, OCTOCRYLENE BONDI SANDS (USA) INC. 2b142875-d413-aebe-e063-6394a90aaca0 2025-01-06 Warnings Exact identifier application number: M020 glo SKIN BEAUTY Oil Free SPF 40 GLO SKIN BEAUTY OIL FREE SPF 40 Hayden Caleel LLC 6b27a508-8669-418f-bcb2-61a35b79a3a8 2025-01-05 Warnings Exact identifier application number: M020 glo SKIN BEAUTY Luminous Liquid Foundation SPF 18 GLO SKIN BEAUTY LUMINOUS LIQUID FOUNDATION SPF 18 Hayden Caleel LLC dd863361-281d-45fe-a8c1-6e4c670809a5 2025-01-05 Warnings Exact identifier application number: M020 glo Skin Beauty C-Shield Anti-Pollution Moisture Tint Broad Spectrum SPF 30 GLO SKIN BEAUTY C-SHIELD ANTI-POLLUTION MOISTURE TINT BROAD SPECTRUM SPF 30 Hayden Caleel LLC 9dbe250b-1b88-43b7-8e24-c1f5aaba0f8d 2025-01-05 Warnings Exact identifier application number: M020 Wildberry Lip Balm LIP BALM Casad Company Inc. 5e13dc33-67b7-4461-bec5-0c3edc72f8b4 2025-01-03 Warnings Exact identifier application number: M020 Iced Pear Lip Balm LIP BALM Casad Company Inc. 1d9a62dd-c11e-4f97-9164-edc84adbe05b 2025-01-03 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Sandalwood ZINC OXIDE EVER FAME PTE. LTD. 2ace641a-b440-d0b3-e063-6394a90a8632 2025-01-03 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Sepia ZINC OXIDE EVER FAME PTE. LTD. 2acf4b3b-e82d-d512-e063-6294a90a3fef 2025-01-03 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Truffle ZINC OXIDE EVER FAME PTE. LTD. 2acf4b3b-e830-d512-e063-6294a90a3fef 2025-01-03 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Walnut ZINC OXIDE EVER FAME PTE. LTD. 2acf75d2-8ad7-1bd3-e063-6294a90ac0be 2025-01-03 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Wheat ZINC OXIDE EVER FAME PTE. LTD. 2acf92a1-6d2a-5517-e063-6294a90a7488 2025-01-03 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Warm Vanilla ZINC OXIDE EVER FAME PTE. LTD. 2acf9020-c779-31c2-e063-6294a90a1ab5 2025-01-03 Warnings Exact identifier application number: M020 Earths Daughter Eucalyptus Mint SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad009bc-29ce-0ba6-e063-6294a90a7580 2025-01-03 Warnings Exact identifier application number: M020 Earths Daughter Bing Cherry SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad07286-f8af-7a9f-e063-6394a90a6a24 2025-01-03 Warnings Exact identifier application number: M020 Earths Daughter Vanilla Bean SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad0db95-a283-3c91-e063-6294a90ae523 2025-01-03 Warnings Exact identifier application number: M020 Earths Daughter Strawberry Breeze SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad129b7-4ecd-a967-e063-6294a90ad8c4 2025-01-03 Warnings Exact identifier application number: M020 Earths Daughter Citrus Blast SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad18f4b-4251-be82-e063-6394a90acac5 2025-01-03 Warnings Exact identifier application number: M020 Earths Daughter Creamy Coconut SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad1bb50-869e-8122-e063-6294a90ac724 2025-01-03 Warnings Exact identifier application number: M020 Glow Baby Brightening Setting Mist SPF 45 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Pacifica Beauty, LLC f2f53cf9-3717-07ff-e053-2a95a90a03fb 2025-01-03 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82046-992-01 82046099201 1 TUBE in 1 CARTON (82046-992-01) / 40 mL in 1 TUBE 1 tube 2024-04-01 No No Current 82046-992-02 82046099202 15 TUBE in 1 CARTON (82046-992-02) / 5 mL in 1 TUBE 15 tube 2026-05-14 No No Current