SPF 50 MINERAL SUNSCREEN BKIDS- zinc oxide stick

SPF 50 Mineral Sunscreen by

Drug Labeling and Warnings

SPF 50 Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by KAS Direct LLC dba BabyGanics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredients

Zinc oxide 21.6%
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.

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
- apply liberally and evenly 15 minutes before sun exposure
- reapply:
  - after 80 minutes of swimming or sweating
  - immediately after towel drying
  - at least every 2 hours
- this product is meant for targeted protection and small areas of exposed skin
- for full protection use in conjunction with another sunscreen lotion or spray
- 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

isopropyl palmitate, ozokerite, cetyl alcohol, neopentyl glycol diethylhexanoate, caprylic/capric triglyceride, butyloctyl salicylate, silica, beeswax, isostearic acid, 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, caprylyl glycol, centella asiatica (gotu kola) extract, daucus carota stavia (carrot) seed oil, euphorbia cerifera (candelilla) wax, polyhydroxystearic acid, rubus idaeus (raspberry) seed oil

1 Certified Organic Ingredient Unless otherwise specified, product not labeled as organic. *Learn about these and all our ingredients and the choices we make at babyganics.com/products

SPL UNCLASSIFIED SECTION

dist. by KAS
Direct, LLC
san francisco, ca
94111

PRINCIPAL DISPLAY PANEL - 45 g Container Label

tear
free

kids
by babyganics®

easy rub-in

SPF 50
mineral sunscreen

dermatologist tested

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

Discover which of our ingredients are certified
organic inside the back label.

1118956
NET WT 1.6 OZ (45 g)

PRINCIPAL DISPLAY PANEL - 45 g Container Label

INGREDIENTS AND APPEARANCE

SPF 50 MINERAL SUNSCREEN BKIDS
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-2201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	216 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)
CETYL ALCOHOL (UNII: 936JST6JCN)
CARROT SEED OIL (UNII: 595AO13F11)
CANDELILLA WAX (UNII: WL0328HX19)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOSTEARIC ACID (UNII: X33R8U0062)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
CERESIN (UNII: Q1LS2UJO3A)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)
RASPBERRY SEED OIL (UNII: 9S8867952A)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
SUNFLOWER OIL (UNII: 3W1JG795YI)
Water (UNII: 059QF0KO0R)
TOMATO SEED OIL (UNII: 7N87T9C06T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 59062-2201-4	45 g in 1 CONTAINER; Type 0: Not a Combination Product	03/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M020	03/01/2021

Labeler - KAS Direct LLC dba BabyGanics (002764605)