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

Sente Daily Repair Complex by

Drug Labeling and Warnings

Sente Daily Repair Complex by is a Otc medication manufactured, distributed, or labeled by Owen Biosciences, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients                  Purpose

(Zinc Oxide) 3.72%                 Sunscreen

(Titanium Dioxide) 9.95%        Sunscreen

PURPOSE

USES

Helps protect against sunburn

Higher SPF gives more sunburn protection

Provides moderate protection against sunburn.

WARNINGS

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.

INDICATIONS & USAGE

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENTE DAILY REPAIR COMPLEX  SPF 30
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59958-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	9.95 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	3.72 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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)	7.0 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)	2.0 g  in 100 g
FERRIC OXIDE RED (UNII: 1K09F3G675)	.116 g  in 100 g
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)	.116 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59958-220-02	1 in 1 BOX	04/02/2015
1	NDC: 59958-220-01	30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/02/2015

Labeler - Owen Biosciences, Inc. (790003045)