Your browser does not support JavaScript! SPF15 SUNSCREEN (OCTINOXATE,OXYBENZONE,OCTISALATE) SPRAY [YUYAO JESSIE COMMODITY CO.,LTD.]
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SPF15 SUNSCREEN (octinoxate,oxybenzone,octisalate) spray
[Yuyao Jessie Commodity Co.,Ltd.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

Active Ingredient

Octinoxate 4.0%
oxybenzone 4.0%
Octisalate 2.0%

Purpose

Sunscreen

Use

Use in well ventilated areas

WARNINGS

For External use only.
Not to be swallowed.Avoid contact with eyes.Discontinue use if signs of irritation or rash appear.Use on children under 6 months of age only with advice of a physician.Keep this and all drug out of the reach of children.In case of accidental ingestion,seek professional assistance or contact a Poision Control Center immediately

keep out of reach of children

Use on children under 6 months of age only with advice of a physician.Keep this and all drug out of the reach of children.

Directions

For best results ,apply 15-30 minutes before sun exposure ,Hold bottle 4-6 inches away from body and apply liberally,spraying slowly and evenly until product is visible on skin.can be applied diredtly to wet skin.reapply after swimming ,excessive perspiration,towel drying or extended sun exposure.Do not apply in windy conditions.Do not spray into face.Spray into hand and apply to the face.Use in well ventilated areas.

Inactive ingredients

ALCOHOL Denat,Glycerin ,Tocopherol ,Fragrance,Deionized WATER ,POLYSORBATE 20

lebel

image

SPF15 SUNSCREEN 
octinoxate,oxybenzone,octisalate spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51414-600
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (OCTINOXATE) Octinoxate4 g  in 100 g
oxybenzone (OXYBENZONE) oxybenzone4 g  in 100 g
Octisalate (OCTISALATE) Octisalate2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
glycerin 
tocopherol 
WATER 
POLYSORBATE 20 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51414-600-015 g in 1 PACKAGE
2NDC:51414-600-027 g in 1 PACKAGE
3NDC:51414-600-038 g in 1 PACKAGE
4NDC:51414-600-0410 g in 1 PACKAGE
5NDC:51414-600-0512 g in 1 PACKAGE
6NDC:51414-600-0615 g in 1 PACKAGE
7NDC:51414-600-0720 g in 1 PACKAGE
8NDC:51414-600-0825 g in 1 PACKAGE
9NDC:51414-600-0930 g in 1 PACKAGE
10NDC:51414-600-1040 g in 1 PACKAGE
11NDC:51414-600-1150 g in 1 PACKAGE
12NDC:51414-600-1260 g in 1 PACKAGE
13NDC:51414-600-1370 g in 1 PACKAGE
14NDC:51414-600-1480 g in 1 PACKAGE
15NDC:51414-600-1590 g in 1 PACKAGE
16NDC:51414-600-16100 g in 1 PACKAGE
17NDC:51414-600-17120 g in 1 PACKAGE
18NDC:51414-600-18130 g in 1 PACKAGE
19NDC:51414-600-19150 g in 1 PACKAGE
20NDC:51414-600-20160 g in 1 PACKAGE
21NDC:51414-600-21180 g in 1 PACKAGE
22NDC:51414-600-22200 g in 1 PACKAGE
23NDC:51414-600-23220 g in 1 PACKAGE
24NDC:51414-600-24250 g in 1 PACKAGE
25NDC:51414-600-25300 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/12/2012
Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)
Establishment
NameAddressID/FEIBusiness Operations
Yuyao Jessie Commodity Co.,Ltd.529892305manufacture(51414-600)

Revised: 11/2012
 
Yuyao Jessie Commodity Co.,Ltd.

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