FDA.reportPublic FDA data

Mineral Sunscreen SPF 50 - Kayura Effect LLC | ALAINA HEALTHCARE PRIVATE LIMITED

Manufacturer
Kayura Effect LLC | ALAINA HEALTHCARE PRIVATE LIMITED
Effective date
2026-10-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-13 04:04:42

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 doctor if 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
84771-00184771-001-50

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
ZINC OXIDESOI2LOH54ZACTIB
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

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 97 · 1,937 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsName fallback
generic name: ZINC OXIDE
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsName fallback
generic name: ZINC OXIDE
Sunski Hot Block Mineral Sunscreen Stick SPF 50ZINC OXIDEStewart Charley Ventures LLC dba Sunski04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a82026-09-01WarningsName fallback
generic name: ZINC OXIDE
Sunceutical SPF 50 Mineral Face CreamZINC OXIDEBaxter Laboratories Pty. Ltd.2c408728-a1de-d51e-e063-6294a90ade0b2026-08-31WarningsName fallback
generic name: ZINC OXIDE
ISNTREE HYALURONIC ACID NATURAL SUNCREAMZINC OXIDEISNTREE Inc.5a3a59b2-18b6-521b-e063-6294a90a29582026-08-29WarningsName fallback
generic name: ZINC OXIDE
Utu Broad Spectrum SPF 30 Moisturizing Body SunscreenZINC OXIDEUtu Co59938ace-c97c-d758-e063-6394a90a77e42026-08-28WarningsName fallback
generic name: ZINC OXIDE
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen UnscentedZINC OXIDEUtu Co5982e790-7cdb-c96c-e063-6394a90a02d42026-08-28WarningsName fallback
generic name: ZINC OXIDE
Utu Hydrating Sun Balm Broad Spectrum SPF 50ZINC OXIDEUtu Co59d1d0ac-2444-d6f9-e063-6294a90ae80c2026-08-28WarningsName fallback
generic name: ZINC OXIDE
Hello Bello Mineral Sunscreen SPF 50ZINC OXIDETopiderm, Inc.54f12764-5c37-4a05-bf96-209fedb93fd12026-08-28WarningsName fallback
generic name: ZINC OXIDE
Hero Force Shield Superlight Sunscreen SPF 30ZINC OXIDEChurch & Dwight Co., Inc.140268a9-adb9-4574-ad82-4a2e924dc8082026-08-26WarningsName fallback
generic name: ZINC OXIDE
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela59cf1d1e-e951-9d58-e063-6394a90af0f32026-08-24WarningsName fallback
generic name: ZINC OXIDE
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela163f388e-849d-4b7e-93c1-9045d77a9ec22026-08-21WarningsName fallback
generic name: ZINC OXIDE
ClaraVieZINC OXIDEGentell LLC596abd98-17d7-2a22-e063-6294a90af57d2026-08-19WarningsName fallback
generic name: ZINC OXIDE
Utu Broad Spectrum SPF 50 Tinted Sunscreen-StickZINC OXIDEUtu Co596e17d3-3064-1cda-e063-6294a90af9632026-08-19WarningsName fallback
generic name: ZINC OXIDE
MedprideZINC OXIDEShield Line LLCe2689cae-e347-4c0b-825b-6281a0b7c2f12026-08-18WarningsName fallback
generic name: ZINC OXIDE
Zinc OxideZINC OXIDEADUSA Distribution, LLC5940399c-31e3-6d51-e063-6294a90a8e7c2026-08-17Warnings, Adverse reactionsName fallback
generic name: ZINC OXIDE
Sun Zapper - Acne Pure Zinc Sunscreen SPF50ZINC OXIDEVeganic SKN Limited3ee435a5-70fb-0c8a-e063-6394a90a650a2026-08-16WarningsName fallback
generic name: ZINC OXIDE
ISNTREE HYALURONIC ACID SENSITIVE SUNSCREENZINC OXIDEISNTREE Inc.58e38665-0bca-fb02-e063-6394a90ad62a2026-08-13WarningsName fallback
generic name: ZINC OXIDE
TENA Proskin protective creamZINC OXIDEEssity HMS North America Inc.b840377f-a297-4aff-900e-7ea8b7c987172026-08-13Warnings, Adverse reactionsName fallback
generic name: ZINC OXIDE
Elta MD Skincare UV Stick Broad Spectrum SPF50ZINC OXIDECP Skin Health Group, Inc58dd81db-46d4-d763-e063-6394a90abb0b2026-08-12WarningsName fallback
generic name: ZINC OXIDE

Reported adverse events (FAERS/openFDA)#

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