NEXT CELL MEDICAL SOOTHING COMPLEX- calming lotion broad spectrum spf 25 sunscreen lotion 
OMP, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

OBAGI MEDICAL SOOTHING COMPLEX
Calming Lotion
Broad Spectrum SPF 25 Sunscreen

Drug Facts

Active Ingredient

Titanium dioxide 4.80%

Purpose

Sunscreen

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

Warnings

For external use only

Do Not Use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

rash occurs

Keep out of reach of children

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

Directions

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

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

Inactive Ingredients

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?

1.800.636.7546

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

Principal Display Panel – 47 mL Label

OBAGI MEDICAL

SOOTHING COMPLEX

Calming Lotion

Broad Spectrum SPF 25 Sunscreen

BY SUZAN OBAGI MD

Nextcell Logo

1.6 fl.oz. (47 mL)

Obagi Medical Soothing Complex Calming Lotion SPF 25 Sunscreen - Carton
NEXT CELL MEDICAL  SOOTHING COMPLEX
calming lotion broad spectrum spf 25 sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-602
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE480 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SHEA BUTTER (UNII: K49155WL9Y)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PROPANEDIOL (UNII: 5965N8W85T)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
RANUNCULUS FICARIA (UNII: YO2M043F0W)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHYTONADIONE (UNII: A034SE7857)  
PINEAPPLE JUICE (UNII: O4KOG0B1KC)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
METHYLCELLULOSE (1500 MPA.S) (UNII: P0NTE48364)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ALUMINUM MONOSTEARATE (UNII: P9BC99461E)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERROUS OXIDE (UNII: G7036X8B5H)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
ALLANTOIN (UNII: 344S277G0Z)  
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
SORBIC ACID (UNII: X045WJ989B)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BROMELAINS (UNII: U182GP2CF3)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
BROCCOLI SPROUT (UNII: 128UH9LOAE)  
CHAMOMILE (UNII: FGL3685T2X)  
CUCUMBER (UNII: YY7C30VXJT)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
HONEY (UNII: Y9H1V576FH)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
TETRAPEPTIDE-4 (UNII: S9N5X165MO)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-602-1547 mL in 1 TUBE; Type 0: Not a Combination Product02/05/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/05/2018
Labeler - OMP, Inc. (790553353)
Registrant - Valeant Pharmaceuticals North America LLC (042230623)
Establishment
NameAddressID/FEIBusiness Operations
G.S. Cosmeceutical USA, Inc.017014734MANUFACTURE(62032-602)

Revised: 1/2018
Document Id: fe954524-ff18-414d-989a-676a123a88c2
Set id: 414d7c6d-76d9-42f6-9644-6f4da3732ae5
Version: 2
Effective Time: 20180111
 
OMP, Inc.