SURFACE SUN SPF 50 DRY TOUCH FRAGRANCE FREE- homosalate 10.00% octocrylene 6.00% avobenzone 3.00% lotion

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredients             Purpose          

Avobenzone 3.00%................Sunscreen
Homosalate 10.00%..............Sunscreen
Octocrylene 6.00%................Sunscreen                   

PURPOSE

Uses

helps prevent sunburn higher SPF gives more sun protection

DOSAGE & ADMINISTRATION

Directions
apply liberally to cool, dry skin 15 minutes before sun exposure reapply:
after 80 minutes of swimming or sweating immediately after towel
drying at least every 2 hours
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 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 shirts, pants, hats, and sunglasses.
children under 6 months: Ask a doctor.

WARNINGS

Warnings
For external use only.
Do not useon damaged or broken skin.
When using this product Keep out of eyes. Rinse with water to remove.
Stop use and ask doctor ifrash occurs.

KEEP OUT OF REACH OF CHILDREN

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

INACTIVE INGREDIENT

Inactive ingredientsAloe Barbadensis Leaf Juice, Aluminum Starch
Octenylsuccinate, Aminomethyl Propanol, Benzyl Alcohol, Butyloctyl
Salicylate, Carbomer, Dimethicone, Ethylhexylglycerin, Inulin, Lauric Acid,
Magnesium Chloride, Myristic Acid, Palmitic Acid, Phenoxyethanol,
Polyglyceryl-3 Distearate, Sodium Phytate, Sorbitan Isostearate, Sorbitol,
Stearic Acid, VP/Eicosene Copolymer, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SURFACE SUN SPF 50 DRY TOUCH FRAGRANCE FREE 
homosalate 10.00% octocrylene 6.00% avobenzone 3.00% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72344-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
AMINOMETHYL PROPANOL (UNII: LU49E6626Q)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CARBOMER (UNII: 0A5MM307FC)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INULIN (UNII: JOS53KRJ01)
LAURIC ACID (UNII: 1160N9NU9U)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
MYRISTIC ACID (UNII: 0I3V7S25AW)
PALMITIC ACID (UNII: 2V16EO95H1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
SODIUM PHYTATE (UNII: 88496G1ERL)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72344-116-03	88 mL in 1 TUBE; Type 0: Not a Combination Product	05/05/2026
2	NDC: 72344-116-06	177 mL in 1 PACKAGE; Type 0: Not a Combination Product	05/05/2026

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

Labeler - Surface Products Corp (010777036)

Registrant - Inspec Solutions LLC (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(72344-116)