TOTAL EYE CARE SPF 15

Main information

  • Trade name:
  • TOTAL EYE CARE SPF 15- titanium dioxide lotion
  • Composition:
  • Titanium Dioxide 45 mg in 1 mL
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TOTAL EYE CARE  SPF 15- titanium dioxide lotion
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Sunscreen - helps prevent sunburn - if used as directed with other sun protection measures (see Directions), may decrease the risk of skin cancer and early skin aging caused by the sun.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 68479-360-00, 68479-360-01, 68479-360-02
  • Last update:
  • 30-05-2019

Summary of Product characteristics: dosage, interactions, side effects

TOTAL EYE CARE SPF 15- titanium dioxide lotion

Dermalogica

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.

----------

Total Eye Care

SPF 15

Drug Facts

Active ingredient

Titanium Dioxide (4.5%)

Purpos e

Sunscreen

Us es

helps prevent sunburn

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

skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Do not use on broken or damaged skin.

When using this product keep out of eyes. Rinse with water to remove.

If irritation develops, discontinue use.

Do not use on infants under 6 months old.

Stop use and ask a physician if too much skin irritation or sensitivity develops or increases.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Directions

Apply evenly 15 minutes before sun exposure.

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

After cleansing in the morning, gently pat around the entire eye area, blending inward from the outer

corner.

Inactive ingredients

Water (Aqua), C12-15 Alkyl Ethylhexanoate, Butylene Glycol, Glycerin, Silica, Lactic Acid, Cetearyl

Alcohol, Potassium Cetyl Phosphate, Magnesium Aluminum Silicate, Glyceryl Stearate, PEG-100

Stearate, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Spiraea Ulmaria Flower Extract,

Centella Asiatica Extract, Taurine, Leucine, Valine, Tyrosine, Arginine, Lysine, Sodium PCA,

Tocopheryl Acetate, Bisabolol, Lauric Acid, Aluminum Hydroxide, Allantoin, Ceteareth-20, Xanthan

Gum, Sodium Hydroxide, Propylene Glycol, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol,

Talc, Iron Oxides (CI 77492, CI 77491), Mica (CI 77019).

Ques tions ?

1-800-831-5150 in USA

PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton

total

care

broad

spectrum

NPN #80011194

0.5 US Fl. Oz.

15 mL e

dermalogica

®

TOTAL EYE CARE SPF 15

titanium dioxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 479 -36 0

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

45 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

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

Glycerin (UNII: PDC6 A3C0 OX)

Silico n Dio xide (UNII: ETJ7Z6 XBU4)

La ctic Acid (UNII: 33X0 4XA5AT)

Ceto stea ryl Alco ho l (UNII: 2DMT128 M1S)

Po ta ssium Cetyl Pho spha te (UNII: 0 3KCY6 P7UT)

Ma g nesium Aluminum Silica te (UNII: 6 M3P6 4V0 NC)

Glyceryl Mo no stea ra te (UNII: 230 OU9 XXE4)

PEG-10 0 Stea ra te (UNII: YD0 1N19 9 9 R)

Po lyo xyl 2 0 Ceto stea ryl Ether (UNII: YRC528 SWUY)

Citrus Aura ntium Flo wer (UNII: O730 ZX2Z8 3)

Pheno xyetha no l (UNII: HIE49 2ZZ3T)

Pro pylene Glyco l (UNII: 6 DC9 Q16 7V3)

So dium Pyrro lido ne Ca rbo xyla te (UNII: 46 9 OTG57A2)

Filipendula Ulma ria Flo wer (UNII: 0 6 L18 L32G6 )

Centella Asia tica (UNII: 7M8 6 7G6 T1U)

So dium Hydro xide (UNII: 55X0 4QC32I)

Aluminum Hydro xide (UNII: 5QB0 T2IUN0 )

Lysine (UNII: K3Z4F9 29 H6 )

Xa ntha n Gum (UNII: TTV12P4NEE)

Levo meno l (UNII: 24WE0 3BX2T)

Arg inine (UNII: 9 4ZLA3W45F)

La uric Acid (UNII: 116 0 N9 NU9 U)

Edeta te Diso dium (UNII: 7FLD9 1C8 6 K)

Ta urine (UNII: 1EQV5MLY3D)

Tyro sine (UNII: 42HK56 0 48 U)

De rmalogica

Tyro sine (UNII: 42HK56 0 48 U)

Ethylhexylg lycerin (UNII: 147D247K3P)

.Alpha .-To co phero l Aceta te (UNII: 9 E8 X8 0 D2L0 )

Alla nto in (UNII: 344S277G0 Z)

Leucine (UNII: GMW6 7QNF9 C)

Va line (UNII: HG18 B9 YRS7)

Ta lc (UNII: 7SEV7J4R1U)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

BARIUM CARBO NATE (UNII: 6 P6 6 9 D8 HQ8 )

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

Product Characteristics

Color

PINK

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 479 -36 0 -0 2

1 in 1 CARTON

1

15 mL in 1 TUBE

2

NDC:6 8 479 -36 0 -0 1

4 mL in 1 TUBE

3

NDC:6 8 479 -36 0 -0 0

2 mL in 1 POUCH

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 3/29 /20 12

Labeler -

Dermalogica (177698560)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pa kLa b

1777110 8 2

MANUFACTURE(6 8 479 -36 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Diamo nd Wipes

16 110 4729

MANUFACTURE(6 8 479 -36 0 )

Revised: 12/2013