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

Kids SPF 50 plus Sunscreen by

Drug Labeling and Warnings

Kids SPF 50 plus 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

Titanium Dioxide 7.9%, Zinc Oxide 6.7%
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
- keep outer card for full drug facts
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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

SPF 50 PLUS SUNSCREEN ALL MINERAL ACTIVE INGREDIENTS
titanium dioxide and zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-1200
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	79 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	67 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 59062-1200-1	1 in 1 BLISTER PACK	06/21/2013
1		13 g in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 59062-1200-2	2 in 1 BLISTER PACK	06/21/2013
2		13 g in 1 APPLICATOR; 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	06/21/2013

KIDS SPF 50 PLUS SUNSCREEN ALL MINERAL ACTIVE INGREDIENTS
titanium dioxide and zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-2200
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	79 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	67 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 59062-2200-4	45.5 g in 1 APPLICATOR; Type 0: Not a Combination Product	06/21/2013	12/31/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M020	06/21/2013	12/31/2025

Labeler - KAS Direct LLC dba BabyGanics (002764605)