FDA.reportPublic FDA data

Mineral Sunscreen SPF 50 - ALAINA HEALTHCARE PRIVATE LIMITED

Manufacturer
ALAINA HEALTHCARE PRIVATE LIMITED
Effective date
2026-06-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-15 00:32:51

Label at a glance#

ProductMineral Sunscreen SPF 50
Active ingredientZINC OXIDE
Label structure9 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 generously and evenly 15 minutes before sun exposure Reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours. 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: Limi...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Mineral Sunscreen

Protects skin from sun damage

100% Mineral

SPF 50

U VA + U V B

Broad Spectrum SPF 50

Water Resistant (40 Minutes)​​​​​​​

Active Ingredients                                                                        Purpose

OTC - ACTIVE INGREDIENT SECTION

​​​​​​​​​​​​​​Zinc Oxide 20%..........................................................................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 on damaged or broken skin. When using this product keep out of eyes.Rinse with water to remove. Stop use and ask a doctorif rash occurs. Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply generously and evenly 15 minutes before sun exposure

Reapply:

  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours.

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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Asparagus Racemosus Root Extract, C12-15 Alkyl Benzoate, C13-15 Alkane, Caprylic/Capric Triglyceride, Citric Acid, Cyperus Rotundus Root Extract, Dibutyl Adipate, Disteardimonium Hectorite, Ectoin, Ethylhexylglycerin, Glycerin, HDI/Trimethylolhexyllactone Crosspolymer, Neopentyl Glycol Diheptanoate, Pentylene Glycol, Phenoxyethanol, Picrorhiza Kurroa Root Extract, Polyester-7, Polyglyceryl-2 Oleate, Polyglyceryl-2 Stearate, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-4 Oleate, Polyglyceryl-6 Oleate, Polyhydroxystearic Acid, Propanediol, Sodium Gluconate, Squalane, Tocopheryl Acetate, VP/Eicosene Copolymer, Water/Aqua/Eau.

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Questions?

OTC - QUESTIONS SECTION

Email us at or visit

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mineral Sunscreen - Carton Label

"Image Description""Image Description"​​​​​​​

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73492-72073492-720-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPARAGUS RACEMOSUS ROOTY8P1YR4920IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
C13-15 ALKANE114P5I43UJIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CYPERUS ROTUNDUS TUBER4B51SRR959IACT
DIBUTYL ADIPATEF4K100DXP3IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ECTOINE7GXZ3858RYIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
PENTYLENE GLYCOL50C1307PZGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PICRORHIZA KURROA ROOTZB5K2O2999IACT
POLYESTER-70841698D2FIACT
POLYGLYCERYL-2 OLEATE5759J47SAMIACT
POLYGLYCERYL-2 STEARATE253MC0P0YVIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
POLYGLYCERYL-4 OLEATE15B05TY4GXIACT
POLYGLYCERYL-6 OLEATEG4AYJ54K59IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PROPANEDIOL5965N8W85TIACT
SODIUM GLUCONATER6Q3791S76IACT
SQUALANEGW89575KF9IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIB

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
Mineral Sunscreen SPF 50MINERAL SUNSCREENALAINA HEALTHCARE PRIVATE LIMITED7e036f9f-b26d-4f11-911c-c1fa854edb0f2026-06-17WarningsExact identifier
ndc (package): 73492-720-50
ndc (product): 73492-720
ndc11 (package): 73492072050
spl id: 546d39cb-259d-e90c-e063-6394a90a5f44
spl set id: 7e036f9f-b26d-4f11-911c-c1fa854edb0f

Reported adverse events (FAERS/openFDA)#

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