Label: CLEAN FRESH SUNBLOCK SUNSCREEN SPF 30 CONTINUOUS- homosalate spray
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Contains inactivated NDC Code(s)
NDC Code(s): 71712-001-01 - Packager: Wuxi Huoban Daily-use Chemical Science and Technology Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated August 29, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
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
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INACTIVE INGREDIENT
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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLEAN FRESH SUNBLOCK SUNSCREEN SPF 30 CONTINUOUS
homosalate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71712-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 13 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:71712-001-01 150 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/29/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/29/2017 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 Name Address ID/FEI Business Operations Wuxi Huoban Daily-use Chemical Science and Technology Co., Ltd. 421207374 manufacture(71712-001)
