SURFACE SPF 50 3OZ TINTED MINERAL SUNSCREEN WITH WATER RESISTANCE- 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

Uses

Helps prevent sunburn.Higher SPF gives more sun protection.

WARNINGS

WARNINGS

For external use only.

When using this product:

Stop use and ask a doctor ifrash occurs.

Inactive Ingredeints

Allantoin
Aloe Barbadensis Leaf Juice
Butylene Glycol
Butyloctyl Salicylate
Butyrospermum Parkii (Shea) Butter
Caprylhydroxamic Acid
Caprylic/Capric Triglyceride
Caprylyl Caprylate/Caprate
Caprylyl Glyceryl Ether
Cetearyl Olivate
Cucumis Sativus (Cucumber) Seed Oil
Dicaprylyl Carbonate
Dimethicone
Ethylhexylglycerin
Ethylhexyl Methoxycrylene
Fragrance
Helianthus Annuus (Sunflower) Seed Oil
Hydrogenated Castor Oil
Inulin
Iron Oxides (CI 77491)
Iron Oxides (CI 77492)
Iron Oxides (CI 77499)
Isopropyl Myristate
Jojoba Esters
Magnesium Chloride
Magnesium Sulfate
Niacinamide
Octyldodecanol
Phenoxyethanol
Polyglyceryl-2 Oleate
Polyglyceryl-3 Polyricinoleate
Polyhydroxystearic Acid
Propanediol
Sorbitan Oleate
Sorbitan Olivate
Synthetic Beeswax
Tocopheryl Acetate
Trihydroxystearin
VP/Hexadecene Copolymer
Water

DOSAGE & ADMINISTRATION

DIRECTIONS

Apply liberally 15 minutes before sun exposure.

Reapply after 80 minutes of swimming or sweating , after towel drying, at least every 2 hours

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 and ask Doctor if rash occurs

ASK DOCTOR

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SURFACE SPF 50 3OZ TINTED MINERAL SUNSCREEN WITH WATER RESISTANCE 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72344-112
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
ALLANTOIN (UNII: 344S277G0Z)
ALOE (UNII: V5VD430YW9)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
DIMETHICONE (UNII: 92RU3N3Y1O)
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)
SHEA BUTTER (UNII: K49155WL9Y)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)
CAPRYLYL GLYCERYL ETHER (UNII: MI97BW74XZ)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CUCUMBER SEED OIL (UNII: AKP926H71P)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
FRAGRANCE CUCUMBER ALOE ORC1802955 (UNII: FSS3TH6V9M)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM)
PROPANEDIOL (UNII: 5965N8W85T)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72344-112-03	88 mL in 1 TUBE; Type 0: Not a Combination Product	05/04/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/04/2026

Labeler - Surface Products Corp (010777036)

Registrant - Inspec Solutions LLC (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(72344-112)