LA ROCHE-POSAY LABORATOIRE PHARMACEUTIQUE ROSALIAC UV FORTIFYING ANTI-REDNESS MOISTURIZER SPF 15- avobenzone octisalate octocryl

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Avobenzone 1.98%, Octislate 3.3%, Octocrylene 4.62

Available from:

Laboratoires Industriels de Vichy (LIDV)

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

LA ROCHE-POSAY LABORATOIRE PHARMACEUTIQUE ROSALIAC UV FORTIFYING
ANTI-REDNESS MOISTURIZER SPF 15- AVOBENZONE OCTISALATE OCTOCRYLENE
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
Avobenzone 1.98%
Octislate 3.3%
Octocrylene 4.62
USES DIRECTIONS
US ES
helps prevent sunburn
higher SPF gives more sunburn protection
protects from 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 PHARMACEUTIQUE ROSALIAC UV
FORTIFYING ANTI-REDNESS MOISTURIZER SPF 15
avobenzone octisalate octocrylene lotion
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 6 38 2-542
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
AVO BENZO NE (UNII: G6 3QQF2NOX) (Avo benzo ne - UNII:G6 3QQF2NOX)
Avo be nz o ne
0 .8 mL in 40 mL
Laboratoires Industriels de Vichy (LIDV)
O CTISA LA TE (UNII: 4X49 Y0 59 6 W) (Octisalate - UNII:4X49 Y0 59 6
W)
O c tisa la te
1.32 mL in 40 mL
O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (Octo crylene - UNII:5A6 8 WGF6
WM)
O c to c ryle ne
1.8 48 mL in 40 mL
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 6 38 2-542-0 1
1 in 1 CARTON
1
40 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
12/0 1/20 0 9
LABELER -
Laboratoires Industriels de Vichy (LIDV) (282658798)
ESTAB