BABY SUNSCREEN SPF 50- titanium dioxide 3.1% zinc oxide 4.0% lotion 
Meijer

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.

----------

Drug Facts

Active ingredients                                                               Purpose
Titanium Dioxide 3.1%........................................................Sunscreen
Zinc Oxide 4.0%..................................................................Sunscreen

Uses • helps prevent sunburn

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 • Apply liberally 15 minutes before sun exposure
• Reapply: • after 80 minutes of swimming or sweating
• immediately after towel drying • at least every 2 hours • 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 the product in this container from
excessive heat and direct sun • may stain fabrics.

Inactive ingredients

Aloe Barbadensis Leaf Extract, Alumina,
Butyloctyl Salicylate, Caprylic/ Capric Triglyceride Caprylyl Glycol Cetyl
PEG/PPG-10/1 Dimethicone, Dimethicone Ethylhexyl Methoxycrylene,
Glycerin, Isohexadecane, Lauryl PEG-8 Dimethicone Octyldodecyl
Citrate Crosspolymer PEG-8, Phenoxyethanol
Sodium Chloride, Sodium Citrate, Tocopheryl
Acetate, Triethoxycaprylylsilane, VP/Eicosene
Copolymer Water.

Questions? 866-483-2846

image description

BABY SUNSCREEN SPF 50 
titanium dioxide 3.1% zinc oxide 4.0% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-902
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide3.1 g  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Dimethicone (UNII: 92RU3N3Y1O)  
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
Glycerin (UNII: PDC6A3C0OX)  
Isohexadecane (UNII: 918X1OUF1E)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Sodium Chloride (UNII: 451W47IQ8X)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-902-06296 mL in 1 BOTTLE; Type 0: Not a Combination Product03/14/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/14/2017
Labeler - Meijer (006959555)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(41250-902) , label(41250-902)

Revised: 6/2018
Document Id: 8063cc09-7fbd-4968-8cd8-16b77820d295
Set id: 1eae935f-942b-4290-91de-8c608f70a7ed
Version: 1
Effective Time: 20180629
 
Meijer