AVEENO POSITIVELY RADIANT CC EYE BROAD SPECTRUM SPF25 - FAIR TO LIGHT- titanium dioxide cream

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

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Active ingredient:
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)
Available from:
Johnson & Johnson Consumer Inc.
INN (International Name):
Titanium Dioxide
Composition:
Titanium Dioxide 18.8 mg in 1 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
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
Authorization status:
OTC monograph not final
Authorization number:
58232-0010-1

AVEENO POSITIVELY RADIANT CC EYE BROAD SPECTRUM SPF25 - FAIR TO LIGHT-

titanium dioxide cream

Johnson & Johnson Consumer 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.

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Aveeno Positively Radiant Eye CC Cream Broad Spectrum SPF 25 - fair to light

Drug Facts

Active Ingredient

Titanium Dioxide (1.88%)

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 and evenly 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 this product from excessive heat and direct sun

may stain some fabrics

Inactive Ingredients

Water, Cyclopentasiloxane, Talc, Butylene Glycol, Cyclohexasiloxane, Polyglyceryl-4

Diisostearate/Polyhydroxystearate/Sebacate, Ethylhexyl Palmitate, C12-15 Alkyl Benzoate,

Tetrahydroxypropyl Ethylenediamine, Cetyl PEG/PPG-10/1 Dimethicone, Boron Nitride, Cetyl

Dimethicone, Magnesium Sulfate, Ozokerite, Polybutene, Citric Acid, Polymethylsilsesquioxane,

Myristyl Alcohol, 1,2-Hexanediol, Caprylyl Glycol, Cocoglycerides, Saccharomyces Lysate Extract,

Aluminum Starch Octenylsuccinate, Propylparaben, DMDM Hydantoin, Silica Silylate, Alumina,

Glyceryl Laurate, Polyhydroxystearic Acid, Silica, Stearyl Alcohol, Dimethicone,

Triethoxycaprylylsilane, Glycine Soja (Soybean) Seed Extract, Pentaerythrityl Tetra-di-t-butyl

Hydroxyhydrocinnamate, Tocopherol, Hydrogenated Vegetable Glycerides, Chrysanthemum

Parthenium (Feverfew) Flower/Leaf/Stem Juice, Distearyl Ether, Acrylates Copolymer, Magnesium

Carbonate, Pentylene Glycol, Titanium Dioxide, Iron Oxides, Mica

Ques tions ?

Call toll-free 866-428-3366 or 215-273-8755 (collect) or visit www.aveeno.com

Distributed by:

JOHNSON & JOHNSON

CONSUMER PRODUCTS

COMPANY

Division of Johnson & Johnson

Consumer Companies, Inc.

Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton

CC Eye

Cream

with

titanium

dioxide

sunscreen

BROAD

SPECTRUM

SPF 25

fair to

light

sheer tint

instantly

conceals,

brightens

protects

0.50 fl. Oz.

(15 mL)

AVEENO POSITIVELY RADIANT CC EYE BROAD SPECTRUM SPF25 - FAIR

TO LIGHT

titanium dioxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 232-0 0 10

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium Dio xide (UNII: 15FIX9 V2JP) (Titanium Dio xide - UNII:15FIX9 V2JP)

Titanium Dio xide

18 .8 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Cyclo methico ne 5 (UNII: 0 THT5PCI0 R)

Ta lc (UNII: 7SEV7J4R1U)

Butylene Glyco l (UNII: 3XUS8 5K0 RA)

Cyclo methico ne 6 (UNII: XHK3U310 BA)

Ethylhexyl Pa lmita te (UNII: 28 6 59 9 330 9 )

Alkyl ( C12 -15) Benzo a te (UNII: A9 EJ3J6 1HQ)

Edeto l (UNII: Q4R9 6 9 U9 FR)

Bo ro n Nitride (UNII: 2U4T6 0 A6 YD)

MAGNESIUM SULFATE, UNSPECIFIED FO RM (UNII: DE0 8 0 37SAB)

Citric Acid Mo no hydra te (UNII: 29 6 8 PHW8 QP)

Myristyl Alco ho l (UNII: V420 34O9 PU)

1,2 -Hexa nedio l (UNII: TR0 46 Y3K1G)

Ca prylyl Glyco l (UNII: 0 0 YIU5438 U)

Co co -Glycerides (UNII: ISE9 I7DNUG)

Sa ccha ro myces Lysa te (UNII: R8 5W246 Z1C)

Aluminum Sta rch O ctenylsuccina te (UNII: I9 PJ0 O6 29 4)

Pro pylpa ra ben (UNII: Z8 IX2SC1OH)

DMDM Hyda nto in (UNII: BYR0 546 TOW)

Aluminum O xide (UNII: LMI26 O6 9 33)

Glyceryl La ura te (UNII: Y9 8 6 11C0 8 7)

Silico n Dio xide (UNII: ETJ7Z6 XBU4)

Stea ryl Alco ho l (UNII: 2KR8 9 I4H1Y)

Dimethico ne (UNII: 9 2RU3N3Y1O)

Trietho xyca prylylsila ne (UNII: LDC331P0 8 E)

So ybea n (UNII: L7HT8 F1ZOD)

Penta erythrito l Tetra kis( 3 -( 3 ,5-Di-Tert-Butyl-4 -Hydro xyphenyl) Pro pio na te) (UNII: 255PIF6 2MS)

To co phero l (UNII: R0 ZB2556 P8 )

Distea ryl Ether (UNII: SC6 T3MJF8 Y)

Ma g nesium Ca rbo na te (UNII: 0 E53J9 27NA)

Pentylene Glyco l (UNII: 50 C130 7PZG)

Ferric O xide Red (UNII: 1K0 9 F3G6 75)

Mica (UNII: V8 A1AW0 8 8 0 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 232-0 0 10 -1

1 in 1 CARTON

0 5/15/20 15

12/0 1/20 23

1

15 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 MONOGRAPH NOT FINAL part352

0 5/15/20 15

12/0 1/20 23

Johnson & Johnson Consumer Inc.

Labeler -

Johnson & Johnson Consumer Inc. (002347102)

Revised: 1/2019

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