HYDRASHEER MINERAL SUNSCREEN- zinc oxide lotion

HYDRASHEER MINERAL SUNSCREEN by

Drug Labeling and Warnings

HYDRASHEER MINERAL SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by THE OUTSET GROUP LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS
ZINC OXIDE 14.93% …

PURPOSE

PURPOSE
..... SUNSCREEN

INDICATIONS & USAGE

USES

• HELPS PREVENT SUNBURN

WARNINGS

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

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

DOSAGE & ADMINISTRATION

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

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDRASHEER MINERAL SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84436-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	149.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
NIACINAMIDE (UNII: 25X51I8RD4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOSTEARIC ACID (UNII: X33R8U0062)
TOCOPHEROL (UNII: R0ZB2556P8)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
CERAMIDE NP (UNII: 4370DF050B)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPANEDIOL (UNII: 5965N8W85T)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84436-0001-2	1 in 1 BOX	06/24/2024
1	NDC: 84436-0001-1	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 84436-0001-4	1 in 1 BOX	06/24/2024
2	NDC: 84436-0001-3	5 mL in 1 TUBE; 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	06/24/2024

Labeler - THE OUTSET GROUP LLC (111280839)