BOB KIDS SUN BALM SPF 40- zinc oxide 23% cream

BOB Kids Sun Balm SPF 40 by

Drug Labeling and Warnings

BOB Kids Sun Balm SPF 40 by is a Otc medication manufactured, distributed, or labeled by SPF Ventures, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide 23%

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 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply: after 80 minutes of swimming or sweating; immediately after towel drying; at least every 2 hours
• Children under 6 months: 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 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-sleeve shirts, pants, hats, and sunglasses.

Inactive Ingredients

Argan Oil, Behenyl Behenate, Bidens Pilosa Extract, Bisabolol, Butyloctyl Salicylate, C9-12 Alkane, Camellia Seed Oil, Candelilla Wax, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Coco-Caprylate/Caprate, Cottonseed Oil, Flaxseed Oil, Frankincense Extract, Green Tea Leaf Extract, Hemp Seed Oil, Lauroyl Lysine, Meadowfoam Seed Oil, Mica, Murumuru Seed Butter, Polyhydroxystearic Acid, Polyurethane-100, Rice Bran Wax, Shea Butter, Silica, Sunflower Seed Oil, Triethoxycaprylylsilane, Triheptanoin, Tocopheryl Acetate.

Other Information

Protect the product in this container from excessive heat and direct sun.

QUESTIONS

MFG in USA / 1.800.916.7690

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BOB KIDS SUN BALM SPF 40 
zinc oxide 23% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58274-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	23 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ARGAN OIL (UNII: 4V59G5UW9X)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
LEVOMENOL (UNII: 24WE03BX2T)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
BIDENS PILOSA LEAF (UNII: 457932TMZ8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)
CAMELLIA OLEIFERA SEED (UNII: 59ED29FM2J)
CANDELILLA WAX (UNII: WL0328HX19)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
RICE BRAN (UNII: R60QEP13IC)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRIHEPTANOIN (UNII: 2P6O7CFW5K)
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
LAUROYL LYSINE (UNII: 113171Q70B)
COCONUT ALKANES (UNII: 1E5KJY107T)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LINSEED OIL (UNII: 84XB4DV00W)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58274-009-01	1 in 1 BOX	03/20/2023
1		3.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/20/2023

Labeler - SPF Ventures, LLC (055483891)