LA ROCHE-POSAY LABORATOIRE PHARMACETIQUE HYDRAPHASE UV EYES HYDRATING PROTECTIVE CREAM SPF 29- octinoxate titanium dioxide lotio

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

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Produktens egenskaper Produktens egenskaper (SPC)
09-02-2010

Aktiva substanser:

Octinoxate 7.5%, Titanium dioxide 5.6%

Tillgänglig från:

Laboratoires Industriels de Vichy (LIDV)

Administreringssätt:

TOPICAL

Receptbelagda typ:

OTC DRUG

Terapeutiska indikationer:

Uses - helps prevent sunburn - higher SPF gives more sunburn protection - protects against UVA/UVB rays Directions - apply evenly before sun exposure and as needed - children under 6 months of age: ask a doctor

Bemyndigande status:

OTC monograph not final

Produktens egenskaper

                                LA ROCHE-POSAY LABORATOIRE PHARMACETIQUE HYDRAPHASE UV
EYES HYDRATING PROTECTIVE CREAM SPF 29- OCTINOXATE TITANIUM DIOXIDE
LOTION
LABORATOIRES INDUSTRIELS DE VICHY (LIDV)
_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 FACTS
ACTIVE INGREDIENTS
Octinoxate 7.5%
Titanium dioxide 5.6%
USES DIRECTIONS
US ES
helps prevent sunburn
higher SPF gives more sunburn protection
protects against UVA/UVB rays
DIRECTIONS
apply evenly before sun exposure and as needed
children under 6 months of age: ask a doctor
WARNINGS
WARNINGS
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT keep out of eyes. Rinse with water to remove.
STOP USE AND ASK A DOCTOR IF rash or irritation develops and lasts
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison Control Center right
away.
LA ROCHE-POSAY LABORATOIRE PHARMACETIQUE HYDRAPHASE UV
EYES HYDRATING PROTECTIVE CREAM SPF 29
octinoxate titanium dioxide lotion
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 6 38 2-157
Laboratoires Industriels de Vichy (LIDV)
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
O CTINO XA TE (UNII: 4Y5P7MUD51) (Octino xate - UNII:4Y5P7MUD51)
O c tino xa te
1.125 mL in 15 mL
TITA NIUM DIO XIDE (UNII: 15FIX9 V2JP) (Titanium dio xide -
UNII:15FIX9 V2JP)
Titanium dio xide
1.14 mL in 15 mL
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 6 38 2-157-0 1
1 in 1 CARTON
1
15 mL in 1 TUBE
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph no t final
pa rt352
0 9 /0 1/20 0 9
LABELER -
Laboratoires Industriels de Vichy (LIDV) (282658798)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Labo rato ires Industriels de Vichy (LIDV)
28 26 58 79 8
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