BABYGANICS SPF 50 PLUS SUNSCREEN- zinc oxide, octisalate, and octocrylene 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 SPF 50+ SUNSCREEN SPRAY

Drug Facts

Active ingredients

Zinc Oxide 11.20%, Octocrylene 6.0%, Octisalate 5.0%

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, butyloctyl salicylate, stearyl/octyldodecyl citrate crosspolymer, aloe barbadensis leaf juice, glyceryl stearate, polyglyceryl-6 polyricinoleate, helianthus annuus (sunflower) seed oil, solanum lycopersicum (tomato) seed oil, lecithin, polysorbate 60, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil organic, rubus idaeus (raspberry) seed oil, squalane, xanthan gum, polysorbate 80, phenethyl alcohol, glyceryl caprylate, lithium magnesium sodium silicate, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, sorbitan isostearate, citric acid

dist. by KAS Direct, LLC.
Westbury, NY 11590

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

50+
SPF

tear
free

water
resistant

babyganics

SPF 50+
sunscreen
spray

broad spectrum SPF 50+
UVA + UVB protection
water resistant (80 minutes)
non-allergenic • pediatrician &
dermatologist tested

formulated with: Zinc Oxide,
Octocrylene, Octisalate*

formulated without: PABA
phthalates • parabens
fragrances • nano-particles

Discover which of our
ingredients are Certified
Organic on back panel.

6 FL OZ (177 mL)

040-12078-B02

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
BABYGANICS SPF 50 PLUS SUNSCREEN 
zinc oxide, octisalate, and octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-0120
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
LAPONITE (UNII: D703131383)  
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)  
TOMATO SEED OIL (UNII: 7N87T9C06T)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59062-0120-1177 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/2019
Labeler - KAS Direct LLC dba Babyganics (002764605)

Revised: 1/2021
Document Id: 6dc0331d-bcc1-489d-aa50-9d592c298341
Set id: 4075f9dc-c25f-434f-a3fc-a7f896295c3d
Version: 2
Effective Time: 20210115
 
KAS Direct LLC dba Babyganics