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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Owen Biosciences, Inc.

INN (International Name):

Titanium Dioxide

Composition:

Titanium Dioxide 9.95 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

USES Helps protect against sunburn Higher SPF gives more sunburn protection Provides moderate protection against sunburn. 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.

Authorization status:

OTC monograph final

Summary of Product characteristics

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
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 N