SOLAIRE PEAU PARFAITE 100 MINERAL FLUID FLAWLESS SKIN- titanium dioxide, zinc oxide lotion

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

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Active ingredient:
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
Available from:
Yves Rocher Amerique du Nord Inc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- Helps prevent sunburn
Authorization status:
OTC monograph not final
Authorization number:
63505-354-00

SOLAIRE PEAU PARFAITE 100 MINERAL FLUID FLAWLESS SKIN- titanium dioxide, zinc

oxide lotion

Yves Rocher Amerique du Nord 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.

----------

Solaire Peau Parfaite -100% Mineral Fluid Flawless Skin

Drug Facts

Active Ingredients

Titanium Dioxide 2.5%,

Zinc Oxide 7.2%

Purpose

Sunscreen

Use

Helps prevent sunburn

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.

Discontinue 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

Apply generously and evenly every morning on cleansed face and neck 15 minutes before

sun exposure For sunscreen use : 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 am - 2 pm wear hats and sunglasses. For use on children less than 6 months of

age, consult a doctor.

Other Information

Protect the product in this container from excessive heat and direct sun.

Store at 15-30°C (59-86°F)

Inactive ingredients

Water/Eau, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Cyclopentasiloxane,

Diisopropyl Sebacate, Isononyl Isononanoate, Polyglyceryl-6

Polyricinoleate, Polymethylsilsesquioxane, Glycerin, Argania Spinosa Kernel Oil, Polyglyceryl-2

Isostearate, Tocopheryl Acetate, Silica, Phenoxyethanol, Disteardimonium Hectorite,

Polyhydroxystearic Acid, Hydrogenated Castor Oil, Sodium Chloride, Magnesium Stearate, Bisabolol,

Aloe Barbadensis Leaf Juice Powder, Alumina, Isopropyl Myristate, Raspberry Seed Oil Tocopheryl

Succinate Aminopropanediol Esters, Caesalpinia Spinosa Fruit Extract, Bentonite, Vaccinium Vitis-

Idaea Fruit Extract, Kappaphycus Alvarezii Extract, Hydrolyzed Pea Protein, Isopropyl

Titanium Triisostearate, Stearalkonium Hectorite, Olive Oil Decyl Esters, Tocopherol, Citric Acid,

Hydrated Silica, Propylene Carbonate, Lactic Acid, Terminalia Ferdinandiana Fruit Extract,

Saccharide Isomerate, Squalene*, Xanthan Gum, Potassium Sorbate, Gluconolactone, Chlorella

Vulgaris Extract, Sodium Benzoate, Sea Salt/Sel Marin, Calcium Gluconate, Mica, Iron Oxides (CI

77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891). * Botanically derived Dérivé de plantes

Questions?

Call : CAN 1-800-361-2746 / USA 1 - 800-321-3434.

Package Labeling:

SOLAIRE PEAU PARFAITE 100 MINERAL FLUID FLAWLESS SKIN

titanium dioxide, zinc oxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 350 5-354

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

25 mg in 1 mL

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)

ZINC CATION

72 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ETHYLHEXYL PALMITATE (UNII: 28 6 59 9 330 9 )

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

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

ISO NO NYL ISO NO NANO ATE (UNII: S4V5BS6 GCX)

PO LYMETHYLSILSESQ UIO XANE ( 4 .5 MICRO NS) (UNII: 59 Z9 0 7ZB6 9 )

GLYCERIN (UNII: PDC6 A3C0 OX)

ARGAN O IL (UNII: 4V59 G5UW9 X)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

DISTEARDIMO NIUM HECTO RITE (UNII: X6 8 7XDK0 9 L)

HYDRO GENATED CASTO R O IL (UNII: ZF9 4AP8 MEY)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

LEVO MENO L (UNII: 24WE0 3BX2T)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

BENTO NITE (UNII: A3N5ZCN45C)

ISO PRO PYL TITANIUM TRIISO STEARATE (UNII: 9 49 E3KBJ1I)

STEARALKO NIUM HECTO RITE (UNII: OLX6 9 8 AH5P)

O LIVE O IL DECYL ESTERS (UNII: 3AQ222F18 X)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

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

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

PRO PYLENE CARBO NATE (UNII: 8 D0 8 K3S51E)

LACTIC ACID (UNII: 33X0 4XA5AT)

SACCHARIDE ISO MERATE (UNII: W8 K377W9 8 I)

SQ UALENE (UNII: 7QWM220 FJH)

XANTHAN GUM (UNII: TTV12P4NEE)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

Yves Rocher Amerique du Nord Inc

GLUCO NO LACTO NE (UNII: WQ29 KQ9 POT)

CHLO RELLA VULGARIS (UNII: RYQ4R6 0 M0 2)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

CALCIUM GLUCO NATE (UNII: SQE6 VB453K)

MICA (UNII: V8 A1AW0 8 8 0 )

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

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 350 5-354-0 0

1 in 1 BOX

0 5/0 1/20 19

1

30 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 5/0 1/20 19

Labeler -

Yves Rocher Amerique du Nord Inc (201826448)

Revised: 3/2019

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