FDA.reportPublic FDA data

HYDRASHEER MINERAL SUNSCREEN

Manufacturer
THE OUTSET GROUP LLC
Effective date
2026-01-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:31:55

Label at a glance#

ProductHYDRASHEER MINERAL SUNSCREEN
Active ingredientZINC OXIDE
Label structure8 sections

Storage and handling

OTHER INFORMATION • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS
ZINC OXIDE 14.93% …

OTC - PURPOSE SECTION

PURPOSE
..... SUNSCREEN

INDICATIONS & USAGE SECTION

USES

  • HELPS PREVENT SUNBURN

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.
IF SWALLOWED, GET MEDICAL HELP
OR CONTACT A POISON CONTROL
CENTER RIGHT AWAY.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS
• APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE
• CHILDREN UNDER 6 MONTHS OF AGE ASK A DOCTOR
• 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

STORAGE AND HANDLING SECTION

OTHER INFORMATION
• PROTECT THE PRODUCT IN THIS
CONTAINER FROM EXCESSIVE HEAT
AND DIRECT SUN

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS
AQUA/WATER/EAU, ISONONYL ISONONANOATE, PROPANEDIOL, ARGANIA SPINOSA KERNEL OIL, TOCOPHERYL ACETATE, DICAPRYLYL CARBONATE, LAURYL GLUCOSIDE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, 1,2-HEXANEDIOL, POTASSIUM CETYL PHOSPHATE, HYDROGENATED LECITHIN, GLYCERIN, NIACINAMIDE, TREMELLA FUCIFORMIS SPOROCARP EXTRACT, HELIANTHUS ANNUUS SUNFLOWER SEED OIL, CASSIA ANGUSTIFOLIA SEED POLYSACCHARIDE, CANDIDA BOMBICOLA/GLUCOSE/METHYL RAPESEEDATE FERMENT, PONGAMIA PINNATA SEED EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, CERAMIDE NP, CETEARYL ALCOHOL, POLYHYDROXYSTEARIC ACID, SILICA, ETHYLHEXYL METHOXYCRYLENE, TRIETHOXYCAPRYLYLSILANE, COCO-CAPRYLATE CAPRATE, COCO-GLUCOSIDE, TRIHEPTANOIN, HYDROXYACETOPHENONE, XANTHAN GUM, BISABOLOL,CAPRYLIC/CAPRIC TRIGLYCERIDE, CITRIC ACID, C9-12 ALKANE, DILINOLEIC ACID BUTANEDIOL COPOLYMER, ALLANTOIN, BENZOTRIAZOLYL DODECYL P-CRESOL, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, ISOSTEARIC ACID, PHENOXYETHANOL, DIPROPYLENE GLYCOL, LECITHIN, POLYGLYCERYL-3 POLYRICINOLEATE, HYDROXYETHYLCELLULOSE, CASTOR OIL IPDI COPOLYMER, SODIUM HYDROXIDE, TOCOPHEROL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of labelimage of label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84436-0001-1HYDRASHEER MINERAL SUNSCREEN50 mL in 1 BOTTLE, PUMPLOTION503
84436-0001-2HYDRASHEER MINERAL SUNSCREEN1 in 1 BOXLOTION13
84436-0001-3HYDRASHEER MINERAL SUNSCREEN5 mL in 1 TUBELOTION53
84436-0001-4HYDRASHEER MINERAL SUNSCREEN1 in 1 BOXLOTION13

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84436-000184436-0001-1, 84436-0001-2, 84436-0001-3, 84436-0001-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPROPYLENE GLYCOLE107L85C40IACT
SODIUM HYDROXIDE55X04QC32IIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
NIACINAMIDE25X51I8RD4IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ISOSTEARIC ACIDX33R8U0062IACT
TOCOPHEROLR0ZB2556P8IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ALLANTOIN344S277G0ZIACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
PONGAMIA PINNATA SEEDC2BRV53B1VIACT
CERAMIDE NP4370DF050BIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
GLYCERINPDC6A3C0OXIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
ARGANIA SPINOSA SEED8H7X7XB54HIACT
BENZOTRIAZOLYL DODECYL P-CRESOL298PX4M11XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPANEDIOL5965N8W85TIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT

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
47d45442-fc33-d77a-e063-6394a90af4151b282bcf-58e2-d285-e063-6394a90a5b872026-01-07WarningsExact identifier
spl id: 47d45442-fc33-d77a-e063-6394a90af415
spl set id: 1b282bcf-58e2-d285-e063-6394a90a5b87

Reported adverse events (FAERS/openFDA)#

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