BABYGANICS COVER UP BABY SUNSCREEN  30SPF- titanium dioxide and zinc oxide lotion 
KAS Direct LLC dba BabyGanics

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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BabyGanics® Cover-Up Baby! Sunscreen Lotion
30SPF

Drug Facts

Active ingredients

Titanium dioxide 3.0%, Zinc oxide 3.0%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • children under 6 months of age: ask a doctor
  • 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 value 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-sleeved shirts, pants, hats, and sunglasses

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

water, butyloctyl salicylate, cetearyl olivate, cocos nucifera (coconut) oil, sorbitan olivate, caprylic/capric triglyceride, carthamus tinctorius (safflower) seed oil, cetyl alcohol, stearyl/octadodecyl citrate crosspolymer, glycerin, ozokerite, simmondsia chinensis (jojoba) seed oil, butyrospermum parkii (shea) butter, theobroma cacao (cocoa) seed butter, jojoba esters, squalane, glyceryl caprylate, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, sucrose stearate, stearic acid, polyglyceryl-2 caprate, xanthan gum, polyhydroxystearic acid, silica, alumina, trisodium ethylenediamine disuccinate, ethylhexylglycerin, phenoxyethanol

Dist. by:
KAS Direct, LLC.
Hicksville, NY 11801

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label

TEAR
FREE!

PEDIATRICIAN & DERMATOLOGIST
TESTED

BabyGanics®

Moisturizes & Protects • Hypoallergenic

COVER-UP Baby!

30
SPF

Pure Mineral
SUNSCREEN

BROAD SPECTRUM SPF 30
UVA/UVB Protection

NO
Chemical Sunscreen,
PABA, Parabens,
Sulfates, Phthalates,
Nano-Particles
or Fragrances

WATER RESISTANT
(40 MINUTES)

4 FL OZ (118 mL)

Principal Display Panel - 118 mL Tube Label
BABYGANICS COVER UP BABY SUNSCREEN   30SPF
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59062-1227
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE30 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLOCTYL SALICYLATE 
CETEARYL OLIVATE 
COCONUT OIL 
SORBITAN OLIVATE 
MEDIUM-CHAIN TRIGLYCERIDES 
SAFFLOWER OIL 
CETYL ALCOHOL 
MONOSTEARYL CITRATE 
GLYCERIN 
CERESIN 
JOJOBA OIL 
SHEA BUTTER 
COCOA BUTTER 
DECYL JOJOBATE 
SQUALANE 
GLYCERYL CAPRYLATE 
ARACHIDYL ALCOHOL 
DOCOSANOL 
ARACHIDYL GLUCOSIDE 
SUCROSE STEARATE 
STEARIC ACID 
XANTHAN GUM 
POLYHYDROXYSTEARIC ACID (2300 MW) 
SILICON DIOXIDE 
ALUMINUM OXIDE 
TRISODIUM ETHYLENEDIAMINE DISUCCINATE 
ETHYLHEXYLGLYCERIN 
PHENOXYETHANOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59062-1227-1118 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/21/2013
Labeler - KAS Direct LLC dba BabyGanics (002764605)

Revised: 7/2013
Document Id: ad8793ee-6911-4d08-b7ae-e129534bcd8f
Set id: 0da5c6ee-91d9-41c8-90c2-93b096b6d55b
Version: 1
Effective Time: 20130718
 
KAS Direct LLC dba BabyGanics