FDA.reportPublic FDA data

ZINC OXIDE

Manufacturer
Spigen Beauty Inc.
Effective date
2024-08-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:17:12

Label at a glance#

ProductSKINRAYS Protective Bounce Butter Broad Spectrum SPF 30 Mineral Sunscreen by Glam up
Active ingredientZINC OXIDE
Label structure8 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 the sun.

Dosage and administration

Apply liberally as the last step in your skincare routine and 15 minutes before sun exposure Reapply at least every 2 hours Use water resistant sunscreen if swimming or sweating 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 i...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15.4%

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 the sun.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally as the last step in your skincare routine and 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use water resistant sunscreen if swimming or sweating
  • 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
  • Children under 6 months: Ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Caprylic/Capric Triglyceride, C13-15 Alkane, Propanediol, Pentylene Glycol, Isoamyl Laurate, Cetearyl Alcohol, Arachidyl Alcohol, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Calcium Aluminum Borosilicate, Ethylhexyl Palmitate, Arachidyl Glucoside,Behenic Acid, Behenyl Alcohol, Betaine, Caprylhydroxamic Acid, Citric Acid, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Coco-Glucoside, Hydrogenated Lecithin, Iron Oxides CI 77492, Isostearic Acid, Lecithin, Musa Sapientum (Banana) Leaf/Trunk Ectract, Myristic Acid, Octyldodecanol, Polyhydroxystearic Acid, Sodium Citrate, Sodium Dilauramidoglutamide Lysine, Sodium Citrate, Sodium Dilauramidoglutamide Lysine, Sodium Phytate, Stearic Acid, Stearyl Alcohol, Tocopheryl Acetate, Xanthan Gum

Question or comments?

OTC - QUESTIONS SECTION

You may report a serious Adverse event from use of this product to + 1(800) 227-1542

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84656-530-00SKINRAYS Protective Bounce Butter Broad Spectrum SPF 30 Mineral Sunscreen by Glam up50 mL in 1 JARCREAM501
84656-530-00SKINRAYS Protective Bounce Butter Broad Spectrum SPF 30 Mineral Sunscreen by Glam up1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84656-530SKINRAYS PROTECTIVE BOUNCE BUTTER BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN BY GLAM UP (ZINC OXIDE) CREAM [SPIGEN BEAUTY INC.]1Current NDC, 2 package rows20240815_94c0d586-8de5-45d1-8a82-07555996e61d.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84656-53084656-530-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
C13-15 ALKANE114P5I43UJIACT
PROPANEDIOL5965N8W85TIACT
PENTYLENE GLYCOL50C1307PZGIACT
ISOAMYL LAURATEM1SLX00M3MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
SHEA BUTTERK49155WL9YIACT
COCONUT OILQ9L0O73W7LIACT
CALCIUM ALUMINUM BOROSILICATE3JRB8A35M0IACT
ETHYLHEXYL PALMITATE2865993309IACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
BEHENIC ACIDH390488X0AIACT
DOCOSANOL9G1OE216XYIACT
BETAINE3SCV180C9WIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CITRUS AURANTIUM FLOWERO730ZX2Z83IACT
COCO-GLUCOSIDEICS790225BIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ISOSTEARIC ACIDX33R8U0062IACT
BANANA4AJZ4765R9IACT
MYRISTIC ACID0I3V7S25AWIACT
OCTYLDODECANOL461N1O614YIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM DILAURAMIDOGLUTAMIDE LYSINEMNJ7VPT2R5IACT
PHYTATE SODIUM88496G1ERLIACT
STEARIC ACID4ELV7Z65APIACT
STEARYL ALCOHOL2KR89I4H1YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZACTIM

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
SKINRAYS Protective Bounce Butter Broad Spectrum SPF 30 Mineral Sunscreen by Glam upZINC OXIDESpigen Beauty Inc.94c0d586-8de5-45d1-8a82-07555996e61d2024-08-14WarningsExact identifier
ndc (package): 84656-530-00
ndc (product): 84656-530
ndc11 (package): 84656053000
spl id: 1fa1f4d3-f269-509d-e063-6294a90ac51f
spl set id: 94c0d586-8de5-45d1-8a82-07555996e61d

Reported adverse events (FAERS/openFDA)#

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