ZINC OXIDE, TITANIUM DIOXIDE cream

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

MATCHCo Inc.

Адміністрація маршрут:

TOPICAL

Тип рецепту:

OTC DRUG

Терапевтичні свідчення:

Uses - helps prevent sunburn - higher SPF gives more sunburn protection 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 swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask doctor if rash occurs.

Статус Авторизація:

OTC monograph final

Характеристики продукта

ZINC OXIDE, TITANIUM DIOXIDE- ZINC OXIDE, TITANIUM DIOXIDE CREAM
MATCHCO 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._
----------
STATEMENT OF IDENTITY SECTION
DRUG FACTS
_ACTIVE INGREDIENTS PURPOSE_
Titanium Dioxide 4.0% Sunscreen
Zinc Oxide 5.9% Sunscreen
INDICATIONS AND USAGE SECTION
US ES
helps prevent sunburn
higher SPF gives more sunburn protection
_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 swallowed, get medical help or contact a Poison Control Center
right away.
WARNINGS SECTION
_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 swallowed, get medical help or contact a Poison Control Center
right away.
OTHER SAFETY INFORMATION
_OTHER INFORMATION_
protect the product in this container from excessive heat and direct
sun
OTC - ACTIVE INGREDIENT SECTION
_ACTIVE INGREDIENTS PURPOSE_
Titanium Dioxide 4.9% Sunscreen
Zinc Oxide 5.9% Sunscreen
OTC - STOP USE SECTION
STOP USE AND ASK DOCTOR IF rash occurs.
PRINCIPAL DISPLAY PANEL
Dist. By.
MATCHCo, Inc
Santa Monica, CA 90401
ZINC OXIDE, TITANIUM DIOXIDE
zinc oxide, titanium dioxide cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:70 79 8 -415
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9
V2JP)
TITANIUM DIOXIDE
4.9 mg in 1 g
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
5.9 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
PO LYGLYCERYL-3 PO LYD