SENTE DAILY REPAIR COMPLEX  SPF 30- titanium dioxide, zinc oxide cream 
Owen Biosciences, 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.

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Sente Daily Repair Complex

Drug Facts

Active ingredients                  Purpose

(Zinc Oxide) 3.72%                 Sunscreen

(Titanium Dioxide) 9.95%        Sunscreen

USES

Helps protect against sunburn

Higher SPF gives more sunburn protection

Provides moderate protection against sunburn.

Warnings

For external use only. When using this product keep
out of eyes.  Rinse with water to remove. Stop use and
ask doctor if rash and irritation develops and lasts.

Avoid contact with eyes. If product gets into eyes,
rinse thoroughly with water.

Keep out of reach of children. If swallowed, get
medical help or contact poison control center right
away.

Directions

Apply evenly to skin before exposure to sun and as needed.

Reapply as needed or after towel drying or swimming.

For children under 6 months, ask a doctor.

Inactive Ingredients

Cyclopentasiloxane, Cyclo-methicone, Water (Aqua), Dimethicone/Vinyl Dimethicone Cross-polymer, Melanin, Tribehenin, Methyl Methacrylate/Glycol, Calcium Behenate, Sorbitan Isostearate, Dimethiconol, Heparan Sulfate, Alumina, PEG-10 Dimethicone, Silybin, Ascobyl Linoleate, Lysophosphatidic Acid, Plankton Extract, Methicone, hydrogen Dimethicone, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, CI 77492 (Iron Oxide), Polyaminopropyl Biguanide

image description

SENTE DAILY REPAIR COMPLEX   SPF 30
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59958-220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9.95 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.72 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TRIBEHENIN (UNII: 8OC9U7TQZ0) 1.25 g  in 100 g
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) 4.68 g  in 100 g
WATER (UNII: 059QF0KO0R) 7 g  in 100 g
CALCIUM BEHENATE (UNII: J5VFA9V6YG) 1.25 g  in 100 g
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) 1.5 g  in 100 g
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) 1.5 g  in 100 g
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) 0.5 g  in 100 g
METHICONE (20 CST) (UNII: 6777U11MKT) 0.5 g  in 100 g
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) 43 g  in 100 g
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT) 2 g  in 100 g
FERRIC OXIDE RED (UNII: 1K09F3G675) 0.116 g  in 100 g
FERRIC OXIDE YELLOW (UNII: EX438O2MRT) 0.116 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59958-220-021 in 1 BOX04/02/2015
1NDC:59958-220-0130 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/02/2015
Labeler - Owen Biosciences, Inc. (790003045)

Revised: 1/2023
Document Id: f268501f-9087-3831-e053-2995a90a09b2
Set id: c7ef88d4-14bf-444b-a9d8-58455b5bbe7b
Version: 4
Effective Time: 20230116
 
Owen Biosciences, Inc.