LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ROSALIAC DAILY COMPLETE TONE CORRECTING BROAD SPECTRUM SPF 30 SUNSCREEN CC- octinoxate

États-Unis - anglais - NLM (National Library of Medicine)

Achète-le

Ingrédients actifs:
Octinoxate 3%, Octisalate 3.5%, Octocrylene 4.5%, Titanium dioxide 6.2%
Disponible depuis:
L'Oreal USA Products Inc
Mode d'administration:
TOPICAL
Type d'ordonnance:
OTC DRUG
indications thérapeutiques:
Sunscreen - helps prevent sunburn - if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun on damaged or broken skin rash occurs
Statut de autorisation:
OTC monograph not final
Numéro d'autorisation:
49967-422-01, 49967-422-02

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ROSALIAC DAILY COMPLETE

TONE CORRECTING BROAD SPECTRUM SPF 30 SUNSCREEN CC- octinoxate, octisalate,

octocrylene and titanium dioxide cream

L'Oreal USA Products 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.

----------

Drug Facts

Active ingredients

Octinoxate 3%

Octisalate 3.5%

Octocrylene 4.5%

Titanium dioxide 6.2%

Purpos e

Sunscreen

Us es

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin

cancer and early skin aging caused by the sun

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.

Directions

For sunscreen use:

apply generously 15 minutes before sun exposure

reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin

aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or

higher and other sun protection measures including:

limit time in the sun, especially from 10 a.m. – 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

children under 6 months of age: Ask a doctor

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, glycerin, butyrospermum parkii (shea) butter, diisopropyl sebacate, C30-45 alkyl dimethicone,

dimethicone, butylene glycol, sucrose tristearate, ammonium polyacryloyldimethyl taurate,

methylsilanol/silicate crosspolymer, polysorbate 61, fragrance, tocopheryl acetate, sodium stearoyl

glutamate, phenoxyethanol, PEG-12 dimethicone, ethylhexylglycerin, tambourissa trichophylla leaf

extract, dimethiconol, xanthan gum, caprylyl glycol, disodium EDTA; may contain: mica, iron oxides,

titanium dioxide

Questions or comments?

1-888-LRP LABO

1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ROSALIAC DAILY

COMPLETE TONE CORRECTING BROAD SPECTRUM SPF 30 SUNSCREEN

CC

octinoxate, octisalate, octocrylene and titanium dioxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:49 9 6 7-422

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

30 mg in 1 mL

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

35 mg in 1 mL

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

45 mg in 1 mL

L'Oreal USA Products Inc

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

6 2 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

SHEA BUTTER (UNII: K49 155WL9 Y)

DIISO PRO PYL SEBACATE (UNII: J8 T3X56 4IH)

C3 0 -4 5 ALKYL METHICO NE (UNII: NFX9 70 DSI2)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

SUCRO SE TRISTEARATE (UNII: 71I9 3STU5M)

PO LYSO RBATE 6 1 (UNII: X9 E1MY2JQG)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

SO DIUM STEARO YL GLUTAMATE (UNII: 6 5A9 F4P0 24)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PEG-12 DIMETHICO NE (UNII: ZEL54N6 W9 5)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

DIMETHICO NO L ( 10 0 0 0 0 CST) (UNII: OSA9 UP217S)

XANTHAN GUM (UNII: TTV12P4NEE)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

MICA (UNII: V8 A1AW0 8 8 0 )

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:49 9 6 7-422-0 1

1 in 1 CARTON

0 8 /0 1/20 14

1

50 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:49 9 6 7-422-0 2

1 in 1 CARTON

0 8 /0 1/20 14

2

3 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

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 8 /0 1/20 14

Labeler -

L'Oreal USA Products Inc (002136794)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Co smetique Active Pro ductio n

28 26 58 79 8

ma nufa c ture (49 9 6 7-422)

Revised: 12/2017

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