CLEAN FRESH SUNBLOCK SUNSCREEN SPF 30 CONTINUOUS- homosalate spray 
Wuxi Huoban Daily-use Chemical Science and Technology Co., Ltd.

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.

----------

Drug Fact

Active Ingredient:

Avobenzone: 3%

Homosalate: 13%

Octisalate: 5%

Octocrylene: 7%

Oxybenzone: 4%

Purpose:

Sunscreen

Uses:

Helps prevent sunburn

Warning:

For external use only

Do not spray directly into face

Flammable. Do not use near heat, flame, or while smoking

When using this product, avoid spray into eyes. If contact occurs, rinse thoroughyl with water. Do not puncture or incinerate container under pressure. Do not store at temperature above 120F

Stop Use and Ask a Doctor if irritation or rash develops

Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center immediately

Directions:

Apply generously and evenly to all areas avoiding eyes 15-30 minutes before sun exposure.

Spray to hands to apply on face

Reapply as needed or after towel drying, swimming, or persporing

Ask a doctor before use on children

Other Information: Sun Alert: Limit sun exposure, wearing protective clothing, using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of sun

Inactive Ingredient:

Water, Sorbitol, Aluminum Starch Octenyl Succinate, VP/Eicosene Copolymer, Stearic Acid, Triethanolamine, Sorbitan Isostearate, Benzyl Alcohol, Dimethicone, Tocopherol (Natural Vitamin E), Polyglyceryl-3-Diisostearate, Fragrance, Methylparaben, Carbomer, Propylparaben, Disodium EDTA

image description

CLEAN FRESH SUNBLOCK SUNSCREEN SPF 30 CONTINUOUS 
homosalate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71712-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE13 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TOCOPHEROL (UNII: R0ZB2556P8)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DISODIUM HEDTA (UNII: KME849MC7A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71712-001-01150 mL in 1 BOTTLE; Type 0: Not a Combination Product08/29/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/29/2017
Labeler - Wuxi Huoban Daily-use Chemical Science and Technology Co., Ltd. (421207374)
Registrant - Wuxi Huoban Daily-use Chemical Science and Technology Co., Ltd. (421207374)
Establishment
NameAddressID/FEIBusiness Operations
Wuxi Huoban Daily-use Chemical Science and Technology Co., Ltd.421207374manufacture(71712-001)

Revised: 8/2017
Document Id: 57ea4bd2-d45f-4394-e053-2991aa0a2bb4
Set id: a4974c77-7b36-4048-ac9e-1640412c8f03
Version: 1
Effective Time: 20170829
 
Wuxi Huoban Daily-use Chemical Science and Technology Co., Ltd.