DERMATONE MINERAL SPF 30- zinc oxide 20% lotion

Dermatone Mineral SPF 30 by

Drug Labeling and Warnings

Dermatone Mineral SPF 30 by is a Otc medication manufactured, distributed, or labeled by Dermatone Labs LLC, Inspec Solutions LLC, Inspec Solutions LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                 Purpose

Zinc Oxide 20%                        Sunscreen

PURPOSE

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Uses

Helps prevent sunburn, higher SPF gives more sunburn protection

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

For external use only.

When using this product:

Stop use and ask a doctor ifrash occurs.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away

Inactive Ingredeints

WATER
CAPRYLIC/CAPRIC TRIGLYCERIDE
COCO-CAPRYLATE
BUTYLOCTYL SALICYLATE
NIACINAMIDE
POLYHYDROXYSTEARIC ACID
GLYCERIN
PANTHENOL
.ALPHA.-TOCOPHEROL ACETATE
SUCROSE PALMITATE
XANTHAN GUM
CITRIC ACID
SACCHARIDE ISOMERATE
SUCROSE TRISTEARATE
SODIUM STEAROYL GLUTAMATE
BENZYL ALCOHOL
DEHYDROACETIC ACID
SODIUM PHYTATE

DOSAGE & ADMINISTRATION

DIRECTIONS

Apply liberally 15 minutes before sun exposure.

Reapply at least every 2 hours

٠apply to all areas of the skin exposed to the sun.
٠Reapply as needed or after towel drying, swimming, or sweating.

Sun Protection Measures. Spending tme 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from
10 a.m. - 2. p.m. wear a long-sleeve shirt, pants, hats, and sunglasses.
children under 6 months: Ask a doctor.

Do no use: on damage or broken skin

STOP USE

ASK DOCTOR

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMATONE MINERAL SPF 30 
zinc oxide 20% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54414-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
COCO-CAPRYLATE (UNII: 4828G836N6)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID (UNII: 2968PHW8QP)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
SUCROSE TRISTEARATE (UNII: 71I93STU5M)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
SODIUM PHYTATE (UNII: 88496G1ERL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54414-030-02	89 mL in 1 CONTAINER; Type 0: Not a Combination Product	08/21/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/21/2025

Labeler - Dermatone Labs LLC (100928460)

Registrant - Inspec Solutions LLC (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(54414-030)