GENTLE MINENERAL SUNSCREEN SPF30- zinc oxide lotion

Gentle Mineneral Sunscreen by

Drug Labeling and Warnings

Gentle Mineneral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Jakks Pacific, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

  Zinc Oxide 19%

Purpose

  Sunscreen

Uses

•    Helps prevent sunburn
• If used as directed with other sun protection measures (​see Directions​), deceases the risk of skin cancer and early skin aging caused by sun.

Warnings

For Exernal use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes.  Rinse with water to remove.

Stope 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.

Directions

• Apply liberally 15 minutes before sun exposure
• reapply:
•    after 40 minutes of swimming or sweating
•    immediately after towel drying
•    at least every 2 hours
• children under 6 months:Ask a doctor
• ​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 scunscreen 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.

Inactive ingredients

1,2-Hexanediol, Actinidia Chinensis (Kiwi) Fruit Extract, Aloe Barbadensis Leaf Juice, Beeswax, Caprylic/Capric Triglyceride, Cetearyl Nonanoate, Coco-Caprylate, Decylene Glycol, Fragaria Vesca (Strawberry) Fruit Extract, Glycerin, Hydrogenated Castor Oil, Isostearic Acid, Lecithin, Magnesium Sulfate, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyhydroxystearic Acid, Pyrus Malus (Apple) Fruit Extract, Shea Butter Ethyl Esters, Silica, Sodium Chloride, Squalane, Tocopherol, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GENTLE MINENERAL SUNSCREEN  SPF30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71965-351
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	ZINC OXIDE	19 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
KIWI FRUIT (UNII: 71ES77LGJC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARYL NONANOATE (UNII: F6ZWV2F361)
COCO-CAPRYLATE (UNII: 4828G836N6)
FRAGARIA VESCA FRUIT (UNII: CG6IX3GCMU)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ISOSTEARIC ACID (UNII: X33R8U0062)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
APPLE (UNII: B423VGH5S9)
SHEA BUTTER GLYCERETH-8 ESTERS (UNII: 47S52L53WZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SQUALANE (UNII: GW89575KF9)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71965-351-02	1 in 1 CARTON	12/12/2017
1	NDC: 71965-351-01	59 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71965-351-03	30 mL in 1 TUBE; Type 0: Not a Combination Product	12/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/12/2017

Labeler - Jakks Pacific, Inc (928779826)