Label: NEXT CELL MEDICAL SOOTHING COMPLEX- calming lotion broad spectrum spf 25 sunscreen lotion
- NDC Code(s): 62032-602-15
- Packager: OMP, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 11, 2018
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses
- Warnings
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Directions
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- apply liberally 15 minutes before sun exposure
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- use a water resistant sunscreen if swimming or sweating
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- reapply at least every 2 hours
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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:
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- limit time in the sun, especially from 10 a.m. – 2 p.m.
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- wear long-sleeved shirts, pants, hats, and sunglasses
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- children under 6 months: Ask a doctor
- Other information
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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
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- Principal Display Panel – 47 mL Label
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INGREDIENTS AND APPEARANCE
NEXT CELL MEDICAL SOOTHING COMPLEX
calming lotion broad spectrum spf 25 sunscreen lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-602 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 480 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-602-15 47 mL in 1 TUBE; Type 0: Not a Combination Product 02/05/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/05/2018 Labeler - OMP, Inc. (790553353) Registrant - Valeant Pharmaceuticals North America LLC (042230623) Establishment Name Address ID/FEI Business Operations G.S. Cosmeceutical USA, Inc. 017014734 MANUFACTURE(62032-602)
