![(OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) SPRAY [SHANGHAI KEJING CLEANING PRODUCTS CO., LTD.]](https://medic.hrt.org//dailymed/images/acc70903-6f3a-45db-a1d5-f586341d2214/Spray_1.jpg)
![(OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) SPRAY [SHANGHAI KEJING CLEANING PRODUCTS CO., LTD.]](https://medic.hrt.org//dailymed/images/acc70903-6f3a-45db-a1d5-f586341d2214/Spray_2.jpg)
| NDC | 31190-230-01, 31190-230-02 |
| Set ID | acc70903-6f3a-45db-a1d5-f586341d2214 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Shanghai Kejing Cleaning Products Co., Ltd. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- 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.
Close - KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If product swallowed, get
medical help or contact a Poison Control Center right away.
Close - DOSAGE & ADMINISTRATION
Directions
Apply generously & evenly before sun exposure. Reapply as
needed or after towel drying, swimming or sweating.
Ask doctor before using on children under 6 months.
Close - INACTIVE INGREDIENT
Inactive ingredients
Water, Cetearyl Alcohol, Xanthan Gum,
C12-15 Alkyl Benzoate, Myristyl Propionate, Propylene Glycol,
Glyceryl Stearate Citrate, Disodium EDTA, Iodopropynyl
Butylcarbamate, DMDM Hydantoin, Fragrance
Close - STORAGE AND HANDLING
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- 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) CloseEstablishment Name Address ID/FEI Business Operations Shanghai Kejing Cleaning Products Co., Ltd. 526877847 manufacture(31190-230)