Label: - octinoxate, octisalate, oxybenzone, titanium dioxide spray
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Contains inactivated NDC Code(s)
NDC Code(s): 31190-230-01, 31190-230-02 - Packager: Shanghai Kejing Cleaning Products 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 June 25, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
WARNINGS:
Skin Cancer/Skin Aging Alert: Spending time in the sun
increase your risk of skin cancer and early skin aging.
this product had been shown only to prevent sunburn,
not skin cancer or skin aging.
For external use only.
Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
octinoxate, octisalate, oxybenzone, titanium dioxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:31190-230 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g SOYBEAN OIL (UNII: 241ATL177A) (SOYBEAN OIL - UNII:241ATL177A) SOYBEAN OIL 3.0 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.0 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4.0 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) XANTHAN GUM (UNII: TTV12P4NEE) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MYRISTYL PROPIONATE (UNII: P59053E7NJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) EDETATE DISODIUM (UNII: 7FLD91C86K) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) DMDM HYDANTOIN (UNII: BYR0546TOW) Product Characteristics Color Score Shape Size Flavor VANILLA Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:31190-230-01 30 g in 1 BOTTLE; Type 0: Not a Combination Product 06/25/2016 2 NDC:31190-230-02 60 g in 1 PACKAGE; Type 0: Not a Combination Product 06/25/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/25/2016 Labeler - Shanghai Kejing Cleaning Products Co., Ltd. (526877847) Establishment Name Address ID/FEI Business Operations Shanghai Kejing Cleaning Products Co., Ltd. 526877847 manufacture(31190-230)
