LUMIN BROAD SPECTRUM MOISTURIZER WITH SPF 30 PA UVA/UVB PROTECTION SUNSCREEN- zinc oxide cream

Lumin Broad Spectrum Moisturizer with SPF 30 PA UVA/UVB Protection Sunscreen by

Drug Labeling and Warnings

Lumin Broad Spectrum Moisturizer with SPF 30 PA UVA/UVB Protection Sunscreen 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 ofOther Information age: Ask a doctor

Other Information

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

Inactive Ingredients

Water/Aqua/Eau, 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

Package Labeling:81234-808-00

Package Labeling:81234-808-01

Package Labeling:81234-808-02

INGREDIENTS AND APPEARANCE

LUMIN BROAD SPECTRUM MOISTURIZER WITH SPF 30 PA UVA/UVB PROTECTION SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81234-808
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
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
XANTHAN GUM (UNII: TTV12P4NEE)
HEXANEDIOL (UNII: ZIA319275I)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HYDROXYPROPYLBETADEX (0.58-0.68 MS) (UNII: 1I96OHX6EK)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE (UNII: 4828G836N6)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
PROPANEDIOL (UNII: 5965N8W85T)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81234-808-00	1 in 1 BOX	01/01/2022	01/05/2025
1		15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 81234-808-01	1 in 1 BOX	01/01/2022	01/05/2025
2		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3	NDC: 81234-808-02	1 in 1 BOX	01/01/2022	01/05/2025
3		40 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	01/01/2022	01/05/2025

Labeler - Pangaea Holdings Inc. (081181313)