ZINC OXIDE

Manufacturer
Pangaea Holdings, Inc.
Effective date
2024-01-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:13:49

Label at a glance#

ProductLumin Broad Spectrum Moisturizer with SPF 30 PA High UVA/UVB Protection Sunscreen
Active ingredientZINC OXIDE
Label structure4 sections

Dosage and administration

Apply the sunscreen product before sun exposure. Re-apply frequently to maintain protection, especially after perspiring, swimming, or towelling. AM: Start with a clean, dry face and gently rub an almond-sized amount all over the face. PM: Wash off with a gentle cleanser and lukewarm water.

Label contents#

Full prescribing information#

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply the sunscreen product before sun exposure. Re-apply frequently to maintain protection, especially after perspiring, swimming, or towelling.
AM: Start with a clean, dry face and gently rub an almond-sized amount all over the face.
PM: Wash off with a gentle cleanser and lukewarm water.

INGREDIENTS

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Zinc Oxide,  Coco-Caprylate, Dicaprylyl Carbonate, Microcrystalline Cellulose, Glycerin, Cetyl Alcohol, Lauryl Glucoside, Capryloyl Glycerin/Sebacic Acid Copolymer, Propanediol, Diheptyl Succinate, Cellulose Gum, Polyglyceryl-2, Dipolyhydroxystearate, Phytic Acid, Simmondsia Chinensis (Jojoba) Seed Oil*, Helianthus Annuus (Sunflower) Seed Oil*, Rosmarinus Officinalis (Rosemary) Leaf Extract, Carica Papaya (Papaya) Fruit Extract, Haematococcus Pluvialis Extract (Astaxanthin), Palmitoyl Tripeptide-38, Caprylhydroxamic Acid, Xanthan Gum, Polyhydroxystearic Acid, Hydroxypropyl Cyclodextrin, Hexanediol, Triethoxycaprylylsilane *Certified Organic Ingredients

WARNING

WARNINGS SECTION

For external use only. Do not apply to damaged or broken skin. Discontinue use if irritation occurs. Over-exposure to the sun is a serious health threat. Do not stay too long in the sun, even while using a sunscreen product.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep babies and young children out of direct sunlight.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer LabelOuter LabelInner LabelInner Label

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FDA-Initiated Inactive NDC Indexing#

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81234-80781234-807-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

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
0f4bc05c-f1cc-7aa6-e063-6394a90a46811cae5058-365f-426f-bf3f-bff62335ec582024-01-19WarningsExact identifier
spl id: 0f4bc05c-f1cc-7aa6-e063-6394a90a4681
spl set id: 1cae5058-365f-426f-bf3f-bff62335ec58

Reported adverse events (FAERS/openFDA)#

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