MedPath

BOB Kids Sun Balm SPF 40

BOB Kids Sun Balm SPF 40

Approved
Approval ID

efa5c501-273c-5e97-e053-2995a90a865b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 24, 2025

Manufacturers
FDA

SPF Ventures, LLC

DUNS: 055483891

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Zinc Oxide 23%

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code58274-009
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Zinc Oxide 23%
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 24, 2025
FDA Product Classification

INGREDIENTS (27)

ARGAN OILInactive
Code: 4V59G5UW9X
Classification: IACT
INDIAN FRANKINCENSEInactive
Code: 4PW41QCO2M
Classification: IACT
SHEA BUTTERInactive
Code: K49155WL9Y
Classification: IACT
LEVOMENOLInactive
Code: 24WE03BX2T
Classification: IACT
ASTROCARYUM MURUMURU SEED BUTTERInactive
Code: 12V64UPU6R
Classification: IACT
BEHENYL BEHENATEInactive
Code: K8NU647RJ0
Classification: IACT
BIDENS PILOSA LEAFInactive
Code: 457932TMZ8
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
ZINC OXIDEActive
Quantity: 23 g in 100 g
Code: SOI2LOH54Z
Classification: ACTIM
CAMELLIA OLEIFERA SEEDInactive
Code: 59ED29FM2J
Classification: IACT
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YI
Classification: IACT
MEADOWFOAM SEED OILInactive
Code: 412ZHA4T4Y
Classification: IACT
RICE BRANInactive
Code: R60QEP13IC
Classification: IACT
POLYHYDROXYSTEARIC ACID STEARATEInactive
Code: 8KQ7I65XZE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
TRIHEPTANOINInactive
Code: 2P6O7CFW5K
Classification: IACT
LEVANT COTTONSEED OILInactive
Code: N5CFT140R8
Classification: IACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)Inactive
Code: N7YC58165T
Classification: IACT
COCO-CAPRYLATE/CAPRATEInactive
Code: 8D9H4QU99H
Classification: IACT
LAUROYL LYSINEInactive
Code: 113171Q70B
Classification: IACT
COCONUT ALKANESInactive
Code: 1E5KJY107T
Classification: IACT
CANNABIS SATIVA SEED OILInactive
Code: 69VJ1LPN1S
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
LINSEED OILInactive
Code: 84XB4DV00W
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/19/2023

label

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/19/2023

**Uses**

  • Helps prevent sunburn
  • if used as directed with other sun protection measures (seeDirections), decreases the risk of skin cancer and early aging caused by the sun.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/19/2023

Active Ingredients

Zinc Oxide 23%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/19/2023

**Purpose**

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 1/19/2023

**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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/19/2023

**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 INGREDIENT SECTION

LOINC: 51727-6Updated: 1/19/2023

**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 SAFETY INFORMATION

LOINC: 60561-8Updated: 1/19/2023

**Other Information**

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/19/2023

MFG in USA / 1.800.916.7690

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BOB Kids Sun Balm SPF 40 - FDA Drug Approval Details