BABYGANICS SUNSCREEN  50 SPF- octinoxate, octisalate, and zinc oxide 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 50 SPF

Drug Facts

Active ingredients

Octinoxate 7.5%, Octisalate 5.0%, Zinc oxide 11.2%

Purpose

Sunscreen

Uses

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

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

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

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

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

50+
SPF

tear
free

water
resistant

babyganics®

mineral-based
sunscreen spray

broad spectrum SPF 50+
UVA + UVB protection
water resistant (80 minutes)
non-allergenic

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

6 FL OZ (177mL)

040-12078-01

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
BABYGANICS SUNSCREEN   50 SPF
octinoxate, octisalate, and zinc oxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-1207
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE112 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HEXADECYL POVIDONE (UNII: AG75W62QYU)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
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)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SQUALANE (UNII: GW89575KF9)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59062-1207-1177 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: 2/2020
Document Id: 84a18760-a9e0-40c5-bf54-aad5fd4740c7
Set id: 1d6b1153-f59d-4812-ac73-2681e11d51e4
Version: 4
Effective Time: 20200205
 
KAS Direct LLC dba BabyGanics