FDA.reportPublic FDA data

coco glow sun balm

Manufacturer
OSEA Intl, LLC
Effective date
2021-01-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:49:07

Label at a glance#

Productcoco glow sun balm
Active ingredientZinc Oxide
Label structure10 sections

Indications and 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 sun.

Dosage and administration

Gently glide enclosed spatula across the Coco Glow Sun Balm SPF 30 Mineral Sunscreen. Place into the palm of hand. Blend with fingertips until balm melts to a smooth texture. Apply liberally 15 minutes before sun exposure and as needed. Reapply at least every 2 hours. Use water-resistant sunscreen if swimming or sweating. Children under 6 months: ask a doctor. Sun Protection Measures. Spending time in the sun incr...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 18%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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 sun.

Warnings

WARNINGS SECTION

  • For external use only.

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.
  • If product is swallowed, contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Gently glide enclosed spatula across the Coco Glow Sun Balm SPF 30 Mineral Sunscreen. Place into the palm of hand. Blend with fingertips until balm melts to a smooth texture.
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Reapply at least every 2 hours.
  • Use water-resistant sunscreen if swimming or sweating.
  • 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 value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10AM - 2PM.
    • Wear long-sleeve shirts, pants, hats, and sunglasses.

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

COCOS NUCIFERA (Coconut) OIL1, GLYCERYL DIBEHENATE, COCOGLYCERIDES, TRIBEHENIN, GLYCERYL BEHENATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CYLINDROTHECA FUSIFORMIS EXTRACT, PAVLOVA LUTHERI EXTRACT, ORYZA SATIVA (Rice) BRAN EXTRACT, ROSMARINUS OFFICINALIS (Rosemary) LEAF EXTRACT, HELIANTHUS ANNUUS (Sunflower) SEED EXTRACT, TOCOPHEROL, IRON OXIDES (CI 77492, CI 77491, CI 77499)

1 Organic Ingredient

SPL UNCLASSIFIED SECTION

Dist. by OSEA Intl. LLC Malibu, CA 90265

PRINCIPAL DISPLAY PANEL - 47 g Jar Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OSEA

coco glow sun balm

broad spectrum SPF 30
mineral sunscreen

NET WT 47g / 1.6oz.

PRINCIPAL DISPLAY PANEL - 47 g Jar Box
PRINCIPAL DISPLAY PANEL - 47 g Jar Box

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73432-001-012023-08-22C16284748780-1e4f33bdf-aef0-d8a0-e053-dadaa90a6e4ecoco glow sun balm
73432-001-012022-07-29C16284748780-1e4f33bdf-aef0-d8a0-e053-dadaa90a6e4ecoco glow sun balm

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73432-00173432-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
COCONUT OILQ9L0O73W7LIACT
Glyceryl DibehenateR8WTH25YS2IACT
COCO-GLYCERIDESISE9I7DNUGIACT
Tribehenin8OC9U7TQZ0IACT
GLYCERYL MONOBEHENATEA626UU0W2AIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CYLINDROTHECA FUSIFORMISF4J2H3D5OUIACT
DIACRONEMA LUTHERI5N7X0S4J0BIACT
RICE BRANR60QEP13ICIACT
ROSEMARYIJ67X351P9IACT
SUNFLOWER SEEDR9N3379M4ZIACT
TocopherolR0ZB2556P8IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b71a514d-0911-4f06-a843-099d8da1c4082d25eea6-ff15-48ee-8146-ebef3e4baf312023-08-21WarningsExact identifier
spl set id: 2d25eea6-ff15-48ee-8146-ebef3e4baf31

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.