Main information

Documents

Localization

  • Available in:
  • - octinoxate, octisalate, oxybenzone, titanium dioxide spray
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Purpose Sunscreen Uses : Helps prevent sunburn

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 31190-230-01, 31190-230-02
  • Last update:
  • 20-06-2019

Summary of Product characteristics: dosage, interactions, side effects

- octinoxate, octisalate, oxybenzone, titanium dioxide spray

Shanghai Kejing Cleaning Products 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.

----------

Active Ingredients

Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0%,

Titanium Dioxide 2.5%

Purpos e

Sunscreen

Uses: Helps prevent sunburn

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. If product swallowed, get

medical help or contact a Poison Control Center right away.

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.

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

Other information

Protect this product from excessive heat and direct sun

Questions or Comment? Call toll free 1-877-254-2281

Insect repellent active ingredients: soybean oil 3%

octinoxate, octisalate, oxybenzone, titanium dioxide spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:3119 0 -230

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

7.5 g in 10 0 g

Shanghai Kejing Cleaning Products Co., Ltd.

SO YBEAN O IL (UNII: 241ATL177A) (SOYBEAN OIL - UNII:241ATL177A)

SOYBEAN OIL

3.0 g in 10 0 g

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

2.0 g in 10 0 g

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)

OXYBENZONE

4.0 g in 10 0 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

2.5 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

XANTHAN GUM (UNII: TTV12P4NEE)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

MYRISTYL PRO PIO NATE (UNII: P59 0 53E7NJ)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

GLYCERYL STEARATE CITRATE (UNII: WH8 T9 2A0 6 5)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

VANILLA

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:3119 0 -230 -0 1

30 g in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 6 /25/20 16

2

NDC:3119 0 -230 -0 2

6 0 g in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

0 6 /25/20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 6 /25/20 16

Labeler -

Shanghai Kejing Cleaning Products Co., Ltd. (526877847)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Shanghai Kejing Cleaning Pro ducts Co ., Ltd.

526 8 778 47

ma nufa c ture (3119 0 -230 )

Revised: 6/2016