PROVENCE INTENSIVE AMPOULE BB 01 LIGHT BEIGE- titanium dioxide, octinoxate, zinc oxide cream

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

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Active ingredient:
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
Available from:
NATURE REPUBLIC CO., LTD.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Sunscreen
Authorization status:
OTC monograph not final
Authorization number:
51346-519-01, 51346-519-02

PROVENCE INTENSIVE AMPOULE BB 01 LIGHT BEIGE- titanium dioxide, octinoxate, zinc

oxide cream

NATURE REPUBLIC CO., LTD.

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.

----------

ACTIVE INGREDIENT

Active Ingredient: TITANIUM DIOXIDE 7.9%, ETHYLHEXYL METHOXYCINNAMATE 3.0%,

ZINC OXIDE 1.9%

INACTIVE INGREDIENT

Inactive Ingredients:

WATER, CYCLOPENTASILOXANE, TALC, GLYCERIN, PEG-10 DIMETHICONE,

NIACINAMIDE, DIPROPYLENE GLYCOL, ISOEICOSANE, CAPRYLYL METHICONE,

TRIDECYL TRIMELLITATE, CYCLOMETHICONE, DISTEARDIMONIUM HECTORITE,

TRIETHYLHEXANOIN, HEXYL LAURATE, IRON OXIDES(CI 77492), MAGNESIUM SULFATE,

C12-14 PARETH-3, PHENOXYETHANOL, DIMETHICONE/VINYL DIMETHICONE

CROSSPOLYMER, ACRYLATES/DIMETHICONE COPOLYMER, METHICONE, VINYL

DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SILICA, IRON OXIDES(CI

77491), PALMITIC ACID, ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, FRAGRANCE,

ALUMINUM HYDROXIDE, ALUMINUM STEARATE, IRON OXIDES(CI 77499),

DIMETHICONE, ADENOSINE, SODIUM HYALURONATE, ALCOHOL, HYDROLYZED

HYALURONIC ACID, PANAX GINSENG ROOT EXTRACT, LAVANDULA ANGUSTIFOLIA

(LAVENDER) FLOWER WATER, BUTYLENE GLYCOL, ROYAL JELLY, FICUS CARICA (FIG)

FRUIT EXTRACT, MALPIGHIA EMARGINATA (ACEROLA) FRUIT EXTRACT, SALMON EGG

EXTRACT, CARICA PAPAYA (PAPAYA) FRUIT, CORNUS OFFICINALIS FRUIT EXTRACT,

LIPPIA CITRIODORA LEAF EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT,

SODIUM BENZOATE, CITRIC ACID, SILK AMINO ACIDS, PROPOLIS EXTRACT,

OENOTHERA BIENNIS (EVENING PRIMROSE) OIL, SQUALANE, HELIANTHUS ANNUUS

(SUNFLOWER) SEED OIL

PURPOSE

Purpose: Sunscreen

WARNINGS

WARNINGS:

1. For external use only.

2. Avoid contact with eyes and mouth.

3. Discontinue use if signs of irritation or rashes appear.

4. Keep out of reach of children.

5. Replace the cap after use.

DESCRIPTION

Indications & usage: The BB cream provides natural coverage with UV protection.

Dosage & administration: Apply an appropriate amount to the entire face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROVENCE INTENSIVE AMPOULE BB 01 LIGHT BEIGE

NATURE REPUBLIC CO., LTD.

titanium dioxide, octinoxate, zinc oxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:51346 -519

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

3.9 5 g in 50 mL

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

OCTINOXATE

1.50 g in 50 mL

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

ZINC CATION

0 .9 5 g in 50 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:51346 -519 -

1 in 1 CARTON

12/20 /20 16

1

NDC:51346 -519 -0 1

50 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

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

12/20 /20 16

Labeler -

NAT URE REPUBLIC CO., LT D. (631172020)

Registrant -

NAT URE REPUBLIC CO., LT D. (631172020)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ko lmar Ko rea Co ., Ltd.

6 8 9 5126 11

ma nufa c ture (51346 -519 )

Revised: 5/2019

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