SUNCARE ESSENTIALS- titanium dioxide, octisalate, and zinc oxide 
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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suncare essentials

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

SPF 50+ sunscreen stick

Drug Facts

Active ingredients

Titanium Dioxide 7.9%, Zinc Oxide 6.7%

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

Inactive ingredients

C12-15 alkyl benzoate, caprylic/capric triglyceride, beeswax2, copernicia cerifera (carnauba) wax2, neopentyl glycol diethylhexanoate, tribehenin, euphorbia cerifera (candelilla) wax, PPG-3 benzyl ether myristate, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, helianthus annuus (sunflower) seed wax, myristyl myristate, stearyl/octadodecyl citrate crosspolymer, simmondsia chinensis (jojoba) seed oil2, polyglyceryl-10 pentaoleate, jojoba esters, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil2, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil2, rubus idaeus (raspberry) seed oil, polyhydroxystearic acid, caprylyl glycol, ethylhexylglycerin, silica, alumina


2
Certified Organic Ingredient
Unless otherwise specified, product not labeled as organic

dist. by KAS direct, LLC
1600 Stewart Avenue
Westbury, NY 11590

PRINCIPAL DISPLAY PANEL - Kit Package

babyganics

suncare essentials
SPF 50+

we've got
you covered
from head
to toe!

SPF 50+ sunscreen lotion
6 FL OZ (177mL)

SPF 50+
sunscreen stick
Net wt 0.47 OZ (13 g)

PRINCIPAL DISPLAY PANEL - Kit Package
SUNCARE ESSENTIALS 
titanium dioxide, octisalate, and zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-5100
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59062-5100-11 in 1 PACKAGE01/01/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 177 mL
Part 21 APPLICATOR 13 g
Part 1 of 2
SPF 50 PLUS SUNSCREEN 
titanium dioxide, octisalate, and zinc oxide lotion
Product Information
Item Code (Source)NDC:59062-1000
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:59062-1000-6177 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/24/2017
Part 2 of 2
SPF 50 PLUS SUNSCREEN   ALL MINERAL ACTIVE INGREDIENTS
titanium dioxide and zinc oxide stick
Product Information
Item Code (Source)NDC:59062-1200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide79 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE67 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
CANDELILLA WAX (UNII: WL0328HX19)  
PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
Stearyl/Octyldodecyl Citrate Crosspolymer (UNII: PN88NW0KPK)  
JOJOBA OIL (UNII: 724GKU717M)  
Polyglyceryl-10 Pentaoleate (UNII: BH1TF96DJC)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TOMATO SEED OIL (UNII: 7N87T9C06T)  
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59062-1200-113 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/21/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/2017
Labeler - KAS Direct LLC dba BabyGanics (002764605)

Revised: 11/2020
Document Id: bb3ca7dd-8b3d-4ef1-9dd8-caa1bbd20d8a
Set id: 96fd2cf8-cb07-4ec1-8946-8e862f6d8377
Version: 1
Effective Time: 20201104
 
KAS Direct LLC dba BabyGanics