KIDS SPF 50 PLUS SUNSCREEN- titanium dioxide, octisalate, 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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Kids SPF 50+ Sunscreen Lotion

Drug Facts

Active ingredients

Octisalate 5.0%, Titanium Dioxide 3.0%, Zinc Oxide 6.0%

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, neopentyl glycol diethylhexanoate, caprylic/capric triglyceride, stearyl/octyldodecyl citrate crosspolymer, polyglyceryl-2 stearate, simmondsia chinensis (jojoba) seed oil1, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, glyceryl stearate, cetyl alcohol, cocos nucifera (coconut) oil1, glycerin1, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil1, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (red raspberry) seed oil, butyrospermum parkii (shea) butter1, jojoba esters, stearyl alcohol, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, polyhydroxystearic acid, xanthan gum, silica, alumina, ethylhexylglycerin, trisodium ethylenediamine disuccinate, phenoxyethanol


1
Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic

dist. by KAS direct, LLC
San Francisco, CA 94111

PRINCIPAL DISPLAY PANEL - 177 mL Tube Label

water
resistant

50+
SPF

babyganics

kids
SPF 50+
sunscreen lotion

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

formulated with: Zinc Oxide,
Octisalate, Titanium Dioxide*

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

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

6 FL OZ (177mL)

PRINCIPAL DISPLAY PANEL - 177 mL Tube Label
KIDS SPF 50 PLUS SUNSCREEN 
titanium dioxide, octisalate, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-1100
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Stearyl/Octyldodecyl Citrate Crosspolymer (UNII: PN88NW0KPK)  
Polyglyceryl-2 Stearate (UNII: 253MC0P0YV)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
Jojoba Oil (UNII: 724GKU717M)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
Coconut Oil (UNII: Q9L0O73W7L)  
Tomato Seed Oil (UNII: 7N87T9C06T)  
Sunflower Oil (UNII: 3W1JG795YI)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Cranberry Seed Oil (UNII: 73KDS3BW5E)  
Nigella Sativa Seed Oil (UNII: CS4U38E731)  
Raspberry Seed Oil (UNII: 9S8867952A)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Shea Butter (UNII: K49155WL9Y)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
Docosanol (UNII: 9G1OE216XY)  
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Aluminum Oxide (UNII: LMI26O6933)  
Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59062-1100-259 mL in 1 TUBE; Type 0: Not a Combination Product07/24/2017
2NDC:59062-1100-6177 mL in 1 TUBE; Type 0: Not a Combination Product07/24/2017
3NDC:59062-1100-1354 mL in 1 TUBE; Type 0: Not a Combination Product07/24/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/24/2017
Labeler - KAS Direct LLC dba BabyGanics (002764605)

Revised: 7/2020
Document Id: 7856809b-65da-484d-9912-b09a7fc9f721
Set id: a0560078-f37e-4c5d-b46c-103a8cf90b23
Version: 1
Effective Time: 20200715
 
KAS Direct LLC dba BabyGanics