FDA.reportPublic FDA data

Sun Shine Mineral Mouse

Manufacturer
Peer Pharm Ltd.
Effective date
2024-02-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:11:08

Label at a glance#

ProductSun Shine Mineral Mouse
Active ingredientZINC OXIDE
Label structure7 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

shake well before each use spray liberally and spread evenly by hand 15 minutes before sun exposure hold4 to 6 inches from the skin to apply do not spray directly into face. Spray on hands then apply to face do not apply in windy conditions Use in a well-ventilated area reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours

Label contents#

Full prescribing information#

Active Ingredients(in each 30 ml)

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 24.5%

Purpose

OTC - PURPOSE SECTION

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

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product,

OTC - WHEN USING SECTION

  • Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, call a poison control center or get medical help right  away.

Directions

DOSAGE & ADMINISTRATION SECTION

shake well before each use

spray liberally and spread evenly by hand 15 minutes before sun exposure

hold4 to 6 inches from the skin to apply

do not spray directly into face.

Spray on hands then apply to face

do not apply in windy conditions

Use in a well-ventilated area

reapply: after 40 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water,Coco-Caprylate, Styrene/Acrylates Copolymer,Butane,Isobutane, Propane, Octlydodecyl Citrate Crosspolymer,Cetearyl Olivate, Sorbitan Olivate, Caprylyl Glycol, Glycerin, Polyhydroxystearic acid, Aloe Barbadensis Leaf Juice, Panthenol, Triethoxycapryllsilane, Cetearyl Alcohol,Tocopherol, Butyrosperum Parkii (Shea) Butter,Silica, Silica Dimethyl Silyate , Xanthan Gum, Caprylhydroxamix Acid, Propanediol, Sodium Phytate, Dipotassium Glycyrrhizate, Chamomilla Recutita, (Matricaria) Flower Extract ,Calendula Officianlis Flower Extract,Citric Acid

Other Information

SPL UNCLASSIFIED SECTION

  • Store in room temparture
  • protect from freezing
  • may stain clothing

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sun & Shine Mineral Sunscreen Mouse SPF 50Sun & Shine Mineral Sunscreen Mouse SPF 50

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69435-1506-12024-02-20C16284748780-11030e365-6f6b-111a-e063-dadaa90a10e2Sun & Shine Mineral Sunscreen Mouse for face & body SPF 50
69435-1506-12024-01-30C16284748780-11030e365-6f6b-111a-e063-dadaa90a10e2Sun & Shine Mineral Sunscreen Mouse for face & body SPF 50

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69435-1506SUN SHINE MINERAL MOUSE (ZINC OXIDE) LOTION [PEER PHARM LTD.]3Legacy NDC20240221_e29b0f92-278f-e09f-e053-2995a90a35e3.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69435-150669435-1506-1

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
TOCOPHEROLR0ZB2556P8IACT
CITRIC ACID ISOPROPYL ETHER19776V0481IACT
CETEARYL ETHYLHEXANOATE9M64UO4C25IACT
HEXASODIUM PHYTATEZBX50UG81VIACT
CALENDULA OFFICINALIS SEED OIL9JS8DS42SVIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SHEA BUTTERK49155WL9YIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
XANTHAN GUMTTV12P4NEEIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
DIPOTASSIUM GLUCOSE-6-PHOSPHATEZZW95F4360IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CAPRYLYL GLYCOL00YIU5438UIACT
COCO-CAPRYLATE4828G836N6IACT
SODIUM ACRYLATE/STYRENE SULFONATE COPOLYMER (11000 MW)N30934870LIACT
ISOBUTANEBXR49TP611IACT
WATER059QF0KO0RIACT
1-(ETHYLTRISULFANYL)PROPANE4SOS6O9G2XIACT
TRIOCTYLDODECYL CITRATE35X8CT063RIACT
ACRYLATES CROSSPOLYMER-4GEV2EL4D9GIACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
CASTOR OILD5340Y2I9GIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL 1-PHOSPHATE48G71659RBIACT
CHAMOMILEFGL3685T2XIACT
PANTHENOLWV9CM0O67ZIACT
ALOEV5VD430YW9IACT
1,4-BUTANEDITHIOL7JD227IUMCIACT
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
3d2ad4e0-9d04-3577-e063-6294a90aaeb3e29b0f92-278f-e09f-e053-2995a90a35e32025-08-25WarningsExact identifier
spl set id: e29b0f92-278f-e09f-e053-2995a90a35e3

Reported adverse events (FAERS/openFDA)#

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