SPF50 PLUS MINERAL SUNSCREEN- zinc oxide and titanium dioxide 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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SPF50+ Mineral Sunscreen Spray

Drug Facts

Active ingredients

Titanium dioxide 3.5%, Zinc oxide 7.25%

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, isododecane, caprylic/capric triglyceride, isohexadecane, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, shea butter ethyl esters, carthamus tinctorius (safflower) seed oil, C30-38 olefin/isopropyl maleate/MA copolymer, butyloctyl salicylate, coco-glucoside, cetearyl alcohol, cetearyl glucoside, cetearyl olivate, sorbitan olivate, ethylhexylglycerin, simmondsia chinensis (jojoba) seed oil1, sodium hydroxide, chlorphenesin, xanthan gum, tocopherol, glycerin1, sodium phytate, helianthus annuus (sunflower) seed oil1, solanum lycopersicum (tomato) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (raspberry) seed oil, citric acid


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

Dist. by KAS Direct, LLC
1525 Howe St., Racine, WI 53403

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

non
allergenic

tear
free

babyganics®

SPF 50
mineral
sunscreen

pediatrician tested

broad spectrum SPF 50
water resistant (80 minutes)

made without oxybenzone, octinoxate,
parabens, fragrance, nano-particles

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

8 FL OZ (236 mL)

1147142

Principal Display Panel - 236 mL Bottle Label
SPF50 PLUS MINERAL SUNSCREEN 
zinc oxide and titanium dioxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-2210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.25 g  in 100 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide3.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Coco Glucoside (UNII: ICS790225B)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Cetearyl Glucoside (UNII: 09FUA47KNA)  
Cetearyl Olivate (UNII: 58B69Q84JO)  
Sorbitan Olivate (UNII: MDL271E3GR)  
Ethylhexylglycerin (UNII: 147D247K3P)  
JOJOBA OIL (UNII: 724GKU717M)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Chlorphenesin (UNII: I670DAL4SZ)  
Xanthan Gum (UNII: TTV12P4NEE)  
Tocopherol (UNII: R0ZB2556P8)  
Glycerin (UNII: PDC6A3C0OX)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
SUNFLOWER SEED (UNII: R9N3379M4Z)  
TOMATO SEED OIL (UNII: 7N87T9C06T)  
CRANBERRY SEED (UNII: 38ZFO1X2U7)  
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59062-2210-6170 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/01/2022
2NDC:59062-2210-8236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2022
Labeler - KAS Direct LLC dba BabyGanics (002764605)
Establishment
NameAddressID/FEIBusiness Operations
Fruit of the Earth, Inc.080086802MANUFACTURE(59062-2210)

Revised: 3/2022
Document Id: a79c4be1-5458-4bd8-87de-915ca12bfdb4
Set id: 08e8bc10-85d8-4215-8351-7ec12029416c
Version: 1
Effective Time: 20220315
 
KAS Direct LLC dba BabyGanics