babyganics® Sunscreen Spray 30 SPF

babyganics® Sunscreen Spray 30 SPF

Drug Labeling and Warnings

Drug Details

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BABYGANICS 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® 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

30
SPF

tear
free

water
resistant

babyganics®

mineral-based
sunscreen spray

broad spectrum SPF 30
UVA + UVB protection
water resistant (80 minutes)
non-allergenic

no: PABA, phthalates, parabens,
fragrances or nano-particles

6 FL OZ (177mL)

040-12290-01

Principal Display Panel - 177 mL Bottle Label
BABYGANICS SUNSCREEN   30 SPF
zinc oxide, octinoxate, and octisalate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59062-1229
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE112 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXADECYL POVIDONE (UNII: AG75W62QYU)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYGLYCERYL-6 DIOLEATE (UNII: 062SZD3F3X)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
SODIUM MAGNESIUM FLUOROSILICATE (UNII: U1QJ22MC8E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
SQUALANE (UNII: GW89575KF9)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59062-1229-1177 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/21/2013
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: 1/2018
 
KAS Direct LLC dba BabyGanics


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