BABYGANICS COVER UP BABY SUNSCREEN  50SPF- octinoxate, octisalate 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
50SPF .25oz

Drug Facts

Active ingredients

Octinoxate 7.5%, Octisalate 5.0%, Zinc oxide 11.7%

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 80 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, glyceryl stearate, caprylic/capric triglyceride, propanediol, cyclopentasiloxane, stearyl/octadodecyl citrate crosspolymer, cetyl alcohol, cetearyl alcohol, polysorbate 60, dimethicone crosspolymer, glycerin, tocopheryl acetate, sodium stearoyl glutamate, beeswax, lauryl PEG/PPG-18/18 methicone, triethoxycaprylylsilane, xanthan gum, ethylhexylglycerin, disodium EDTA, potassium sorbate, phenoxyethanol, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil, rubus idaeus (red raspberry) seed oil

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

PRINCIPAL DISPLAY PANEL - 12 Single-Use Tubes Bag

EVERYWHERE
ON
THE
GO

Car, Diaper Bag, Stroller

TEAR
FREE!

BabyGanics®

Moisturizes & Protects • Hypoallergenic
COVER-UP Baby!

50+
SPF

SUNSCREEN

BROAD SPECTRUM SPF 50+
UVA/UVB Protection
Mineral Based Formula

NO
PABA, Parabens,
Sulfates, Phthalates,
Nano-Particles,
Retinyl Palmitate
or Fragrances

WATER RESISTANT
(80 MINUTES)

0.25 FL OZ (7 mL)

PEDIATRICIAN & DERMATOLOGIST
TESTED

CLEAR WINDOW

12
SINGLE-USE TUBES

0.25 FL OZ (7 mL) EACH

Principal Display Panel - 12 Single-Use Tubes Bag
BABYGANICS COVER UP BABY SUNSCREEN   50SPF
octinoxate, octisalate, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59062-1238
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE50 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE117 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERYL MONOSTEARATE 
MEDIUM-CHAIN TRIGLYCERIDES 
PROPANEDIOL 
CYCLOMETHICONE 5 
MONOSTEARYL CITRATE 
CETYL ALCOHOL 
CETOSTEARYL ALCOHOL 
POLYSORBATE 60 
DIMETHICONE 
GLYCERIN 
.ALPHA.-TOCOPHEROL ACETATE 
YELLOW WAX 
TRIETHOXYCAPRYLYLSILANE 
SODIUM STEAROYL GLUTAMATE 
ETHYLHEXYLGLYCERIN 
LAURYL PEG/PPG-18/18 METHICONE 
POTASSIUM SORBATE 
EDETATE DISODIUM 
PHENOXYETHANOL 
XANTHAN GUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59062-1238-112 in 1 BAG
17 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: 8/2013
 
KAS Direct LLC dba BabyGanics