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

Baby Sunscreen SPF 50 by

Drug Labeling and Warnings

Baby Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Meijer, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

INDICATIONS & USAGE

Uses helps prevent sunburn

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information protect the product in this container from
excessive heat and direct sun may stain fabrics.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-902
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	3.1 g  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-902-06	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/14/2017

Labeler - Meijer (006959555)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(41250-902) , label(41250-902)