FACE AND BODY SUNSCREEN- octinoxate and titanium dioxide lotion 
Navarro Discount Pharmacies,LLC

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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Drug Facts

Active Ingredients

Octyl Methoxycinnamate 7%

Titanium Dioxide 2.8%

Purpose

Sunscreen

Sunscreen

Use

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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 call a Poison Control Center right away.

Directions

Other information

Inactive Ingredients

beeswax, carbomer, cetyl alcohol, dimethicone, disodium edta, fragrance, glycerin, glyceryl stearate se, glyceryl stearate and peg-100 stearate, methylparaben, propylene glycol, propylparaben, stearic acid, triethanolamine, water

Package label

Vida Mia Sunscreen Lotionimage of sunscreen tube

FACE AND BODY SUNSCREEN 
octinoxate and titanium dioxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59970-074
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 mg  in 100 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.8 mg  in 100 mg
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59970-074-01 113400 mg in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/24/2013
Labeler - Navarro Discount Pharmacies,LLC (094930963)

Revised: 1/2013
Document Id: 4bd5270e-9e3a-45a0-9ebb-2953ac12f265
Set id: 0d70dfed-09c8-401e-9a3e-ef227aeb1db1
Version: 1
Effective Time: 20130122
 
Navarro Discount Pharmacies,LLC