LUMIN UV DEFENSE MOISTURIZING BALM BROAD SPECTRUM SPF 30- zinc oxide cream

Lumin UV Defense Moisturizing Balm Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Lumin UV Defense Moisturizing Balm Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Pangaea Holdings, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 20%

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

Directions

For sunscreen use:
Apply liberally 15 minutes before sun exposure
Reapply at least every 2 hours
Use a 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 of age: Ask a doctor

Other Information

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

Inactive Ingredients

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

Package Labeling:

INGREDIENTS AND APPEARANCE

LUMIN UV DEFENSE MOISTURIZING BALM BROAD SPECTRUM SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81234-805
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE (UNII: 4828G836N6)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
FYTIC ACID (UNII: 7IGF0S7R8I)
JOJOBA OIL (UNII: 724GKU717M)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ROSEMARY (UNII: IJ67X351P9)
PAPAYA (UNII: KU94FIY6JB)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPANEDIOL (UNII: 5965N8W85T)
HEXANEDIOL (UNII: ZIA319275I)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81234-805-01	1 in 1 BOX	02/15/2021	01/05/2025
1		30 mL in 1 BOTTLE, PUMP; 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	02/15/2021	01/05/2025

Labeler - Pangaea Holdings, Inc. (081181313)