FDA.reportPublic FDA data

OBAGI MEDICAL SOOTHING COMPLEX Calming Lotion Broad Spectrum SPF 25 Sunscreen

Manufacturer
OMP, Inc. | Valeant Pharmaceuticals North America LLC | G.S. Cosmeceutical USA, Inc.
Effective date
2018-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:54:22

Label at a glance#

ProductNEXT CELL MEDICAL SOOTHING COMPLEX
Active ingredientTITANIUM DIOXIDE
Label structure9 sections

Indications and uses

• helps prevent sunburn • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by sun

Dosage and administration

• apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, e...

Storage and handling

• store at controlled room temperature: 15°C–25°C (59°F–77°F) • protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 4.80%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by sun

Warnings

WARNINGS SECTION

For external use only

Do Not Use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • if product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature: 15°C–25°C (59°F–77°F)
  • protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aqua (water), caprylic/capric triglyceride, glycerin, octyldodecyl stearoyl stearate, cyclopentasiloxane, butyloctyl salicylate, cyclohexasiloxane, butyrospermum parkii (shea) butter, cetyl alcohol, propanediol, sodium stearoyl glutamate, polyhydroxystearic acid, ranunculus ficaria extract, cetearyl glucoside, dimethicone, phytonadione, ananas sativus (pineapple) fruit juice, cetearyl alcohol, methylcellulose, microcrystalline cellulose, glyceryl stearate, aluminum stearate, sorbitan stearate, alumina, benzyl alcohol, iron oxides, aloe barbadensis leaf extract, benzoic acid, cellulose gum, disodium EDTA, butylene glycol, bioflavonoids, allantoin, chondrus crispus (carrageenan), sorbic acid, sodium hydroxide, phenoxyethanol, bromelain, camellia sinensis leaf extract, brassica oleracea italica (broccoli) extract, chamomilla recutita (matricaria) flower extract, cucumis sativus (cucumber) fruit extract, sodium hyaluronate, glucose, xanthan gum, sodium benzoate, honey extract, boswellia serrata extract, aspalathus linearis (rooibos) leaf extract, tetrapeptide-14

Questions or comments?

OTC - QUESTIONS SECTION

1.800.636.7546

Monday–Friday 9 a.m.–4 p.m. Pacific Time

Principal Display Panel – 47 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OBAGI MEDICAL

SOOTHING COMPLEX

Calming Lotion

Broad Spectrum SPF 25 Sunscreen

BY SUZAN OBAGI MD

Nextcell Logo
Nextcell Logo

1.6 fl.oz. (47 mL)

Obagi Medical Soothing Complex Calming Lotion SPF 25 Sunscreen - Carton
Obagi Medical Soothing Complex Calming Lotion SPF 25 Sunscreen - Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62032-602-152025-01-30C16284748780-12cef2736-819c-d83d-e063-dadaa90ab31fOBAGI MEDICAL SOOTHING COMPLEX Calming Lotion Broad Spectrum SPF 25 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-602-15NEXT CELL MEDICALSOOTHING COMPLEX47 mL in 1 TUBELOTION472

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-602NEXT CELL MEDICAL SOOTHING COMPLEX (CALMING LOTION BROAD SPECTRUM SPF 25 SUNSCREEN) LOTION [OMP, INC.]2Legacy NDC, 1 package rows20180205_414d7c6d-76d9-42f6-9644-6f4da3732ae5.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 53 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62032-60262032-602-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 51 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
OCTYLDODECYL STEAROYL STEARATE3D47Q6D93CIACT
CYCLOMETHICONE 50THT5PCI0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CYCLOMETHICONE 6XHK3U310BAIACT
SHEA BUTTERK49155WL9YIACT
CETYL ALCOHOL936JST6JCNIACT
PROPANEDIOL5965N8W85TIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
RANUNCULUS FICARIAYO2M043F0WIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
DIMETHICONE92RU3N3Y1OIACT
PHYTONADIONEA034SE7857IACT
PINEAPPLE JUICEO4KOG0B1KCIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
METHYLCELLULOSE (1500 MPA.S)P0NTE48364IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ALUMINUM MONOSTEARATEP9BC99461EIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
ALUMINUM OXIDELMI26O6933IACT
BENZYL ALCOHOLLKG8494WBHIACT
FERROUS OXIDEG7036X8B5HIACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZOIC ACID8SKN0B0MIMIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
EDETATE DISODIUM7FLD91C86KIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CITRUS BIOFLAVONOIDSBD70459I50IACT
ALLANTOIN344S277G0ZIACT
CHONDRUS CRISPUS CARRAGEENANUE856F2T78IACT
SORBIC ACIDX045WJ989BIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BROMELAINSU182GP2CF3IACT
GREEN TEA LEAFW2ZU1RY8B0IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fe954524-ff18-414d-989a-676a123a88c2414d7c6d-76d9-42f6-9644-6f4da3732ae52018-01-11WarningsExact identifier
spl id: fe954524-ff18-414d-989a-676a123a88c2
spl set id: 414d7c6d-76d9-42f6-9644-6f4da3732ae5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.