CC CREME 02 SOIN PERFECTEUR DE PEAU SKIN PERFECTING- octinoxate, octisalate, titanium dioxide cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Octinoxate 5,99% Octisalate 2% Titanium Dioxide 5,34%, Sunscreen
Available from:
Codif International
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- helps prevent sunburn. - if used as directed with other sun protection measures (see Directions), decreases the risk of sun cancer and early skin aging caused by the sun.
Authorization status:
OTC monograph not final
Authorization number:
66846-011-50

CC CREME 02 SOIN PERFECTEUR DE PEAU SKIN PERFECTING- octinoxate, octisalate,

titanium dioxide cream

Codif International

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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CC CREME 02 Soin Perfecteur de peau Skin Perfecting

Drug facts

Active Ingredients

Octinoxate 5,99%

Octisalate 2%

Titanium Dioxide 5,34%

Purpose

Sunscreen

Uses

helps prevent sunburn.

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

cancer and early skin aging caused by the sun.

Warnings

For external use only

Do not use

on damaged skin 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

apply liberally 15 minutes before sun exposure

reapply at least every two hours

use a water resistant sunscreen if swimming or sweating

Sun protections measures. Spending time in the sun increases your risk of skin cancer and early

skin aging. To decrease this risk, regurlarly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses

children under 6 months: Ask a doctor

Other information

Protect this product from excessive heat and direct sun

Inactive Ingredients

aqua (water) / eau, glycerin, propylheptyl caprylate, dimethicone, dipropylene glycol, glyceryl stearate,

peg-100 stearate, dicaprylyl carbonate, pentaerythrityl distearate, caprylic/capric triglyceride,

isostearyl isostearate, cetearyl alcohol, magnesium aluminum silicate, glycol palmitate, phenoxyethanol,

methyl methacrylate crosspolymer, peg-10 dimethicone, polyglyceryl- 3 diisostearate, ppg-5-ceteth-20,

polymethyl methacrylate, alumina, xanthan gum, dimethiconol, parfum (fragrance), chlorphenesin,

ceteareth-20, hydroxyethyl acrylate /

sodium acryloyldimethyltaurate copolymer, sodium citrate, caprylyl glycol, squalane, citric acid, silica,

dictyopteris polypodioides extract, polysorbate 60, plankton extract, bht, jania rubens extract,

tocopherol, silene uniflora extract, titanium dioxide, iron oxides

Package Labeling:

CC CREME 02 SOIN PERFECTEUR DE PEAU SKIN PERFECTING

octinoxate, octisalate, titanium dioxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 6 8 46 -0 11

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

59 .9 mg in 1 mL

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

OCTISALATE

20 mg in 1 mL

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

TITANIUM DIOXIDE

53.4 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

PRO PYLHEPTYL CAPRYLATE (UNII: 9 9 1Z19 V2OD)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

DICAPRYLYL CARBO NATE (UNII: 6 0 9 A3V1SUA)

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

Codif International

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

PENTAERYTHRITYL DISTEARATE (UNII: 6 9 7WOT8 HNB)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

ISO STEARYL ISO STEARATE (UNII: IV0 Z58 6 Z4Y)

MAGNESIUM ALUMINUM SILICATE (UNII: 6 M3P6 4V0 NC)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

GLYCO L PALMITATE (UNII: T8 0 A3T38 WE)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PEG-10 DIMETHICO NE ( 6 0 0 CST) (UNII: 8 PR7V1SVM0 )

PO LYGLYCERYL-3 DIISO STEARATE (UNII: 46 P231IQV8 )

PPG-5-CETETH-2 0 (UNII: 4AAN25P8 P4)

PO LY( METHYL METHACRYLATE; 4 50 0 0 0 MW) (UNII: Z47NNT4J11)

PO LYO XYL 2 0 CETO STEARYL ETHER (UNII: YRC528 SWUY)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

XANTHAN GUM (UNII: TTV12P4NEE)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

SQ UALANE (UNII: GW8 9 575KF9 )

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

DICTYO PTERIS PO LYPO DIO IDES (UNII: 8 3H6 O5GR42)

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 6 8 46 -0 11-50

1 in 1 CARTON

0 5/13/20 17

1

50 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 5/13/20 17

Labeler -

Codif International (396156010)

Revised: 11/2018

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