PREVAGE CITY SMART- titanium dioxide, zinc oxide emulsion

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

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Active ingredient:
TITANIUM DIOXIDE 6.2% W/W.................Sunscreen ZINC OXIDE 5.6% W/W ............................Sunscreen
Available from:
REVLON
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 skin cancer and early skin aging caused by the sun
Authorization status:
OTC monograph final
Authorization number:
10967-670-62

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PREVAGE CITY SMART- titanium dioxide, zinc oxide emulsion

REVLON

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.

----------

ELIZABETH ARDEN PREVAGE CITY SMART BROAD SPECTRUM HYDRATING SHIELD

ACTIVE INGREDIENTS

TITANIUM DIOXIDE 6.2% W/W.................Sunscreen

ZINC OXIDE 5.6% W/W ............................Sunscreen

INACTIVE INGREDIENTS

CYCLOPENTASILOXANE, WATER/AQUA/EAU, ISODODECANE, DIMETHICONE, C12-15

ALKYL BENZOATE, ISOPROPYL MYRISTATE, PENTYLENE GLYCOL, BUTYLENE GLYCOL,

SILICA DIMETHYL SILYLATE, CAPRYLYL METHICONE,

POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE,

ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, GLYCERIN,

ALUMINUM HYDROXIDE, STEARIC ACID, PEG-9 POLYDIMETHYLSILOXYETHYL

DIMETHICONE, CARNOSINE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE

METHACRYLATE COPOLYMER, ARABIDOPSIS THALIANA EXTRACT, CAMELLIA

SINENSIS LEAF EXTRACT, CAPRYLYL GLYCOL, DISODIUM EDTA, ERGOTHIONEINE,

FERULIC ACID, HYDROGEN DIMETHICONE, HYDROXYDECYL UBIQUINOYL

DIPALMITOYL GLYCERATE, LECITHIN, MICA, MICROCOCCUS LYSATE,

PARFUM/FRAGRANCE, PEG/PPG-18/18 DIMETHICONE, PLANKTON EXTRACT, SODIUM

PCA, TIN OXIDE, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, ALPHA-

ISOMETHYL IONONE, LINALOOL, CHLORPHENESIN, PHENOXYETHANOL, IRON OXIDES

(CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

USES

■ 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

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 product is swallowed, get medical help or contact a Poison Control

Center right away.

DIRECTIONS FOR SUNSCREEN USE

Directions For Sunscreen Use:

■ Apply liberally 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 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

■ Store at room temperature

CARTON ART

PREVAGE CITY SMART

titanium dioxide, zinc oxide emulsion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:10 9 6 7-6 70

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

6 .2 mg in 1 g

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

5.6 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

ARABIDO PSIS THALIANA WHO LE (UNII: AI3L6 0 HQ8 1)

PEG-9 PO LYDIMETHYLSILO XYETHYL DIMETHICO NE (UNII: TYP8 1E471F)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

LINALO O L, ( +/-) - (UNII: D8 1QY6 I8 8 E)

CAPRYLYL TRISILO XANE (UNII: Q9 5M2P1KJL)

ISO METHYL-.ALPHA.-IO NO NE (UNII: 9 XP4LC555B)

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

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

MICA (UNII: V8 A1AW0 8 8 0 )

PEG/PPG-18 /18 DIMETHICO NE (UNII: 9 H0 AO7T79 4)

SO DIUM PYRRO LIDO NE CARBO XYLATE (UNII: 46 9 OTG57A2)

WATER (UNII: 0 59 QF0 KO0 R)

HYDRO GEN DIMETHICO NE ( 2 0 CST) (UNII: 12Z59 IF6 4N)

HYDRO XYDECYL UBIQ UINO YL DIPALMITO YL GLYCERATE (UNII: OV1BT2N8 RC)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

PENTYLENE GLYCO L (UNII: 50 C130 7PZG)

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

PO LYGLYCERYL-3 PO LYDIMETHYLSILO XYETHYL DIMETHICO NE ( 4 0 0 0 MPA.S) (UNII: RLA2U0 5Z4Q)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

ERGO THIO NEINE (UNII: BDZ3DQM9 8 W)

CARNO SINE (UNII: 8 HO6 PVN24W)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

SILICA DIMETHYL SILYLATE (UNII: EU2PSP0 G0 W)

FERULIC ACID (UNII: AVM9 51ZWST)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

STANNIC O XIDE (UNII: KM7N50 LOS6 )

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

GLYCERIN (UNII: PDC6 A3C0 OX)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

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

ISO DO DECANE (UNII: A8 28 9 P6 8 Y2)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Packag ing

REVLON

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:10 9 6 7-6 70 -6 2

40 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 3/14/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

0 3/14/20 19

Labeler -

REVLON (788820165)

Registrant -

REVLON (788820165)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ko lmar Labo rato ries, Inc.

0 0 153510 3

ma nufa c ture (10 9 6 7-6 70 )

Revised: 12/2020

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