SURFACE SUN SPF 50 MINERAL- zinc oxide lotion

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredients                 Purpose

Zinc Oxide 20.00%                 Sunscreen              

PURPOSE

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

Uses

Helps prevent sunburn.

WARNINGS

WARNINGS

For external use only.

When using this product:

Stop use and ask a doctor ifrash occurs.

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Juice
Butylene Glycol
Butyloctyl Salicylate
Caprylic/Capric Triglyceride
Cetearyl Olivate
Dicaprylyl Carbonate
Dimethicone
Ethylhexyl Methoxycrylene
Ethylhexylglycerin
Helianthus Annuus (Sunflower) Seed Oil
Hydrogenated Castor Oil
Inulin
Isopropyl Myristate
Magnesium Sulfate
Magnesium Chloride
Niacinamide
Phenoxyethanol
Polyglyceryl-3 Polyricinoleate
Polyhydroxystearic Acid
Sorbitan Oleate
Sorbitan Olivate
Synthetic Beeswax
Tocopheryl Acetate
VP/Hexadecene Copolymer
Water
Xanthan Gum

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

SURFACE SUN SPF 50 MINERAL 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72344-110
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
ALOE (UNII: V5VD430YW9)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
INULIN (UNII: JOS53KRJ01)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MAGNESIUM SULFATE (UNII: DE08037SAB)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
NIACINAMIDE (UNII: 25X51I8RD4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SORBITAN OLEATE (UNII: 06XEA2VD56)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
VP/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72344-110-03	88 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2025

Labeler - Surface Products Corp (010777036)

Registrant - Inspec Solutions LLC (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(72344-110)