HAMPTON SUN- octinoxate, octisalate, oxybenzone spray 
Inspec Solutions LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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HAMPTON SUN SPF 8/15 SUNSCREEN GEL

Active Ingredients:

Octinoxate - 7.50%

Octisalate - 5.00%

Oxybenzone - 3.00%

Octinoxate - 7.50% .....................Sunscreen.

Octisalate - 5.00% ......................Sunscreen.​

Oxybenzone - 3.00% ..................Sunscre.en.​

Use • helps prevent sunburn.

Warnings

Skin cancer/Skin Aging alert

For external use only

Do noy use on Damage or broken skin

keep out of eyes. Rinse with water to remove. ​


Stop use and ask a doctor if rash occurs.​


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

DIRECTIONS

• Apply liberally 15 minutes before sun exposure.

•Use a water resistant sunscreen if swimming or sweating.

•Reapply at least every 2 hours

•Children under 6 months of age: ask a doctor.

Inactive Ingredients:

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

Dimethicone Crosspolymer, Fragrance, Hydrogenated Polyisobutene, Hydrolyzed Jojoba Esters, Jojoba Esters, Juglans Regia (Walnut) Seed Oil, Mineral OilSorbitan Olivate, Tocopheryl Acetatel, Water

SPF 8 GEL

HAMPTON SUN 
octinoxate, octisalate, oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
C12-15 ALCOHOLS (UNII: 2C8M6XLB5C)  
TRIEPOXYCYCLOHEXASILANE (UNII: 066Q83563R)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)  
WALNUT OIL (UNII: Y0P3555R51)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)  
MINERAL OIL (UNII: T5L8T28FGP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72667-011-01118 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2019
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2019
Labeler - Inspec Solutions LLC. (081030372)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solutions LLC.081030372manufacture(72667-011)

Revised: 6/2019
Document Id: 8a42d397-2538-bca6-e053-2a95a90aa89a
Set id: 8a42d397-2537-bca6-e053-2a95a90aa89a
Version: 1
Effective Time: 20190601
 
Inspec Solutions LLC.