HAMPTON SUN- octinoxate, oxybenzone gel

HAMPTON SUN by

Drug Labeling and Warnings

HAMPTON SUN by is a Otc medication manufactured, distributed, or labeled by Inspec Solutions LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Octinoxate – 4.00%

Oxybenzone - 2.00%

PURPOSE

Octinoxate – 4.00%..................Sunscreen

Oxybenzone - 2.00%...............Sunscreen

INDICATIONS & USAGE

Uses Helps prevent sunburn​

WARNINGS

Warnings

Skin cancer/Skin Aging alert

For external use only

Do not use on Damage or broken skin

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash 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.

DOSAGE & ADMINISTRATION

DIRECTIONS

Apply liberally 15 minutes before sun exposure.

Use water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

​ Children under 6 months of age: ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients:

Aloe Barbadensis Leaf Extract, Benzotriazolyl Dodecyl p-Cresol, C12-15 Alkyl Benzoate, Cyclohexasiloxane, Cyclopentasiloxane

Dimethicone Crosspolymer, Ethylhexyl Palmitate, Fragrance, Hydrogenated Polyisobutene, Hydrolyzed Jojoba Esters, Jojoba Esters, Juglans Regia (Walnut) Seed Oil, Mineral Oil, Sorbitan Olivate, Tocopheryl Acetate, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAMPTON SUN 
octinoxate, oxybenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72667-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE (UNII: V5VD430YW9)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
WALNUT OIL (UNII: Y0P3555R51)
MINERAL OIL (UNII: T5L8T28FGP)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SORBITAN OLIVATE (UNII: MDL271E3GR)
C12-15 ALCOHOLS (UNII: 2C8M6XLB5C)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72667-012-01	118 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2019

Labeler - Inspec Solutions LLC. (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(72667-012)