SPF50 PLUS MINERAL SUNSCREEN- zinc oxide and titanium dioxide spray

SPF50 Plus Mineral Sunscreen by

Drug Labeling and Warnings

SPF50 Plus Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by KAS Direct LLC dba BabyGanics, Fruit of the Earth, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredients

Titanium dioxide 3.5%, Zinc oxide 7.25%
Purpose

Sunscreen
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions) , decreases the risk of skin cancer and early skin aging caused by the sun
Warnings

For external use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctor ifrash occurs

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- apply liberally and spread evenly by hand 15 minutes before sun exposure
- reapply:
  - after 80 minutes of swimming or sweating
  - immediately after towel drying
  - at least every 2 hours
- do not spray directly into face. Spray on hands then apply to face.
- children under 6 months of age: ask a doctor
- Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  - limit time in the sun, especially from 10 a.m.-2 p.m.
  - wear long-sleeved shirts, pants, hats, and sunglasses
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 oil 1, sodium hydroxide, chlorphenesin, xanthan gum, tocopherol, glycerin 1, sodium phytate, helianthus annuus (sunflower) seed oil 1, solanum lycopersicum (tomato) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil 1, rubus idaeus (raspberry) seed oil, citric acid

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

SPF50 PLUS MINERAL SUNSCREEN
zinc oxide and titanium dioxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-2210
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.25 g in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 59062-2210-6	170 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/01/2022
2	NDC: 59062-2210-8	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	02/01/2022

Labeler - KAS Direct LLC dba BabyGanics (002764605)