SPF 50 PLUS SUNSCREEN  ALL MINERAL ACTIVE INGREDIENTS- titanium dioxide and zinc oxide stick 
KIDS SPF 50 PLUS SUNSCREEN  ALL MINERAL ACTIVE INGREDIENTS- titanium dioxide and zinc oxide stick 
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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SPF 50+ Sunscreen Stick
All Mineral Active Ingredients

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, beeswax1, copernicia cerifera (carnauba) wax1, 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 oil1, polyglyceryl-10 pentaoleate, jojoba esters, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil1, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (raspberry) seed oil, polyhydroxystearic acid, caprylyl glycol, ethylhexylglycerin, silica, alumina


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

dist. by KAS direct, LLC
Westbury, NY 11590

PRINCIPAL DISPLAY PANEL - 13 g Applicator Blister Pack

babyganics®

SPF 50 mineral sunscreen

broad spectrum SPF 50

pediatrician
&
dermatologist
tested

water
resistant
(80 minutes)

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

NET WT 0.47 OZ (13 g)

Principal Display Panel - 13 g Applicator Blister Pack

PRINCIPAL DISPLAY PANEL - 45.5 g Applicator Label

50+
SPF

babyganics

kids

SPF 50+ sunscreen stick
all mineral active ingredients

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

formulated with: Titanium
Dioxide, Zinc Oxide*

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

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

Net. Wt. 1.6 OZ (45.5 g)

040-17936-B01

Principal Display Panel - 45.5 g Applicator Label
SPF 50 PLUS SUNSCREEN   ALL MINERAL ACTIVE INGREDIENTS
titanium dioxide and zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem 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:59062-1200-11 in 1 BLISTER PACK06/21/2013
113 g in 1 APPLICATOR; Type 0: Not a Combination Product
2NDC:59062-1200-22 in 1 BLISTER PACK06/21/2013
213 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
KIDS SPF 50 PLUS SUNSCREEN   ALL MINERAL ACTIVE INGREDIENTS
titanium dioxide and zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-2200
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:59062-2200-445.5 g in 1 APPLICATOR; 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: 6/2022
Document Id: 1b144c6f-8c4c-45bd-ac9f-665b4119f156
Set id: 247aae3d-1845-4dd8-b774-b9e8214809a2
Version: 2
Effective Time: 20220608
 
KAS Direct LLC dba BabyGanics