BABYGANICS SUNSCREEN  30SPF- titanium dioxide 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® Sunscreen Lotion 30SPF

Drug Facts

Active ingredients

Titanium dioxide 3.0%, Zinc oxide 3.0%

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, butyloctyl salicylate, cetearyl olivate, cocos nucifera (coconut) oil, sorbitan olivate, caprylic/capric triglyceride, carthamus tinctorius (safflower) seed oil, cetyl alcohol, stearyl/octadodecyl citrate crosspolymer, glycerin, ozokerite, simmondsia chinensis (jojoba) seed oil, butyrospermum parkii (shea) butter, theobroma cacao (cocoa) seed butter, jojoba esters, squalane, glyceryl caprylate, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, sucrose stearate, stearic acid, polyglyceryl-2 caprate, xanthan gum, polyhydroxystearic acid, silica, alumina, trisodium ethylenediamine disuccinate, ethylhexylglycerin, phenoxyethanol

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

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label

30
SPF

tear
free

water
resistant

babyganics®

pure mineral
sunscreen

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

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

4 FL OZ (118mL)

Principal Display Panel - 118 mL Tube Label
BABYGANICS SUNSCREEN   30SPF
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-1227
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE30 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MONOSTEARYL CITRATE (UNII: YWW937R1QR)  
GLYCERIN (UNII: PDC6A3C0OX)  
CERESIN (UNII: Q1LS2UJO3A)  
JOJOBA OIL (UNII: 724GKU717M)  
SHEA BUTTER (UNII: K49155WL9Y)  
COCOA BUTTER (UNII: 512OYT1CRR)  
DECYL JOJOBATE (UNII: ZL61O8TFZU)  
SQUALANE (UNII: GW89575KF9)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
DOCOSANOL (UNII: 9G1OE216XY)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
SUCROSE STEARATE (UNII: 274KW0O50M)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59062-1227-1118 mL in 1 TUBE; 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: eaedc1f5-5b46-4ec1-bb93-563f43f5396c
Set id: 0da5c6ee-91d9-41c8-90c2-93b096b6d55b
Version: 4
Effective Time: 20200204
 
KAS Direct LLC dba BabyGanics