BABYGANICS COVER UP BABY SUNSCREEN  30 SPF- zinc oxide, octinoxate and octisalate spray 
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 Spray
30 SPF

Drug Facts

Active ingredients

Octinoxate 5.0%, Octisalate 4.0%, Zinc oxide 11.2%

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, caprylic/capric triglyceride, glycerin, vp/hexadecene copolymer, aloe barbadensis leaf juice, glyceryl stearate, hexaglyceryl polyricinoleate, polysorbate 80, phenethyl alcohol, glyceryl caprylate, sodium magnesium silicate, xanthan gum, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, squalane, citric acid, lecithin, polysorbate 60, sorbitan isostearate.

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

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

TEAR
FREE!

PEDIATRICIAN & DERMATOLOGIST
TESTED

BabyGanics®

Moisturizes & Protects • Hypoallergenic
COVER-UP Baby!

30
SPF

SUNSCREEN
SPRAY

BROAD SPECTRUM SPF 30
UVA/UVB Protection
Mineral Based Formula

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

WATER RESISTANT
(80 MINUTES)

6 FL OZ (177 mL)

040-01229-0

Principal Display Panel - 177 mL Bottle Label
BABYGANICS COVER UP BABY SUNSCREEN   30 SPF
zinc oxide, octinoxate, and octisalate spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59062-1229
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE112 mg  in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE50 mg  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
MEDIUM-CHAIN TRIGLYCERIDES 
GLYCERIN 
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) 
ALOE VERA LEAF 
GLYCERYL MONOSTEARATE 
POLYGLYCERYL-6 DIOLEATE 
POLYSORBATE 80 
PHENYLETHYL ALCOHOL 
GLYCERYL CAPRYLATE 
SODIUM MAGNESIUM FLUOROSILICATE 
XANTHAN GUM 
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) 
SQUALANE 
CITRIC ACID MONOHYDRATE 
LECITHIN, SOYBEAN 
POLYSORBATE 60 
SORBITAN ISOSTEARATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59062-1229-1177 mL in 1 BOTTLE, DISPENSING
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: c6cb1b09-3025-4273-b3c4-b58031cd6001
Set id: 391a4ec3-b65b-4dbe-bc8f-cb67514c8ef1
Version: 1
Effective Time: 20130717
 
KAS Direct LLC dba BabyGanics