KIDS SPF50 PLUS MINERAL SUNSCREEN CONTINUOUS TOTALLY TROPICAL- zinc oxide and titanium dioxide spray

Kids SPF50 Plus Mineral Sunscreen Continuous Totally Tropical by

Drug Labeling and Warnings

Kids SPF50 Plus Mineral Sunscreen Continuous Totally Tropical 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 use on damaged or broken skin
When using this product
- keep out of eyes. Rinse with water to remove.
- keep away from face to avoid breathing it
- use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
- do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
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
- shake well before each use
- hold can 4-6 inches away from the skin to apply
- spray liberally and spread evenly by hand 15 minutes before sun exposure
- do not spray directly into face. Spray on hands then apply to face.
- do not apply in windy conditions
- use in a well-ventilated area
- reapply:
  - after 80 minutes of swimming or sweating
  - immediately after towel drying
  - at least every 2 hours
- 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
- may stain or damage some fabrics, materials or surfaces
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, fragrance2

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

2 Product formulated with plant-derived fragrance and ingredients chosen with kids in mind. Learn about these and all our ingredients and the choices we make at babyganics.com/products

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 170 g Can Blister Pack Label

twin pack

tear
free

kids
by babyganics®

easy rub-in

SPF 50
mineral
sunscreen
totally tropical

dermatologist tested

broad spectrum SPF 50
water & sweat resistant (80 minutes)

made without oxybenzone, octinoxate, parabens

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

2 - NET WT 6 OZ (170 g) each

Principal Display Panel - 170 g Can Blister Pack Label

INGREDIENTS AND APPEARANCE

KIDS SPF50 PLUS MINERAL SUNSCREEN CONTINUOUS TOTALLY TROPICAL
zinc oxide and titanium dioxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-2400
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 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	3.5 g in 100 g

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: 59062-2400-6	170 g in 1 CAN; Type 0: Not a Combination Product	02/01/2022
2	NDC: 59062-2400-2	2 in 1 BLISTER PACK	06/01/2022
2	NDC: 59062-2400-6	170 g in 1 CAN; Type 0: Not a Combination Product

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)

Name	Address	ID/FEI	Business Operations
Establishment
Fruit of the Earth, Inc.		080086802	MANUFACTURE(59062-2400)