OTC Medication Information: MINERAL TINTED MOISTURIZER SPF 15

MINERAL TINTED MOISTURIZER SPF 15- titanium dioxide lotion
Aveda Corporation

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.

MINERAL TINTED MOISTURIZER SPF 15
OIL FREE LOTION
1.7 FL . OZ/ 50 ML
AVEDA CORPORATION DISTR.
MINNEAPOLIS, MN 54499 7106
ACTIVE INGREDIENT: TITANIUM DIOXIDE, 4.3%
TO USE: APPLY LIBERALLY AS OFTEN AS POSSIBLE BEFORE SUN EXPOSURE
WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. IF IRRITATION PERSISTS CONSULT A HEALTH CARE PRACTITIONER. KEEP OUT OF REACH OF CHILDREN.

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MINERAL TINTED MOISTURIZER SPF 15
titanium dioxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57677-057
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 4.30 mL in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57677-057-01 1 TUBE (TUBE) in 1 CARTON contains a TUBE (57677-057-02)
1 NDC:57677-057-02 50 mL in 1 TUBE This package is contained within the CARTON (57677-057-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/01/2003
Labeler — Aveda Corporation (071352058)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER COSMETICS, LTD 205952385 manufacture
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER N.V. 370151326 manufacture
Establishment
Name Address ID/FEI Operations
Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture
Establishment
Name Address ID/FEI Operations
Aramis Inc. 042918826 manufacture
Establishment
Name Address ID/FEI Operations
Northtec Bristol 949264774 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Northtec Keystone 618107429 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
PADC 1 110482184 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics, Ltd. 255175580 manufacture
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics, Ltd 253616536 manufacture
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics Distribution Center 208579636 manufacture, label, relabel
Establishment
Name Address ID/FEI Operations
Estee Lauder Kabushiki Kaisha 712808195 relabel, repack
Establishment
Name Address ID/FEI Operations
Whitman Laboratories Ltd. 216866277 manufacture
Establishment
Name Address ID/FEI Operations
Aveda Corporation 071352058 manufacture

Revised: 03/2010 Aveda Corporation

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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