Label: LUMIN UV DEFENSE MOISTURIZING BALM BROAD SPECTRUM SPF 30- zinc oxide cream
- NDC Code(s): 81234-805-01
- Packager: Pangaea Holdings, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 19, 2024
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- Drug Facts
- Active Ingredients
- Uses
- Warnings
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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
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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:
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INGREDIENTS AND APPEARANCE
LUMIN UV DEFENSE MOISTURIZING BALM BROAD SPECTRUM SPF 30
zinc oxide creamProduct 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)