SPF 30 SUNSCREEN- octinoxate, oxybenzone and octisalate spray 
Hangzhou Haorun Technology 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.

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SPF 30 Sunscreen Spray

Active Ingredient

Octinoxate 6.0%

Oxybenzone 4.0%

Octisalate 5.0%

sunscreen

Use

Protection from the sun’s damaging effects.

Warnings

For external use only.Not to be swallowed.Avid contact with eyes.Discontinue use if signs  or 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 assisitance or contact and Poision Control Center imdediately.

Do not use near fire,Store at temerature below 120F(48).Use only as directed.intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Direction

For best results,apply 15-30 minutes befroes 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 directly to wet skin.Reapply after swimming,excessive perspiration,towel drying or extended sunexposure .Don not apply in windy conditions.Do not spray into face,Spray into hand and apply to the face.Use in well ventilated areas.

Inactive Ingredient

Alcohal Denat,Glycerin,Tocopherol,Fragrance,Deionized Water,Polysorbate-20

label of sunscreen
SPF 30 SUNSCREEN 
octinoxate oxybenzone octisalate spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57817-300
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL (UNII: 3K9958V90M)  
Glycerin (UNII: PDC6A3C0OX)  
Tocopherol (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57817-300-01 10 g in 1 BOTTLE
2 NDC:57817-300-02 12 g in 1 BOTTLE
3 NDC:57817-300-03 15 g in 1 BOTTLE
4 NDC:57817-300-04 20 g in 1 BOTTLE
5 NDC:57817-300-05 25 g in 1 BOTTLE
6 NDC:57817-300-06 30 g in 1 BOTTLE
7 NDC:57817-300-07 35 g in 1 BOTTLE
8 NDC:57817-300-08 40 g in 1 BOTTLE
9 NDC:57817-300-09 45 g in 1 BOTTLE
10 NDC:57817-300-10 50 g in 1 BOTTLE
11 NDC:57817-300-11 60 g in 1 BOTTLE
12 NDC:57817-300-12 70 g in 1 BOTTLE
13 NDC:57817-300-13 80 g in 1 BOTTLE
14 NDC:57817-300-14 90 g in 1 BOTTLE
15 NDC:57817-300-15 100 g in 1 BOTTLE
16 NDC:57817-300-16 110 g in 1 BOTTLE
17 NDC:57817-300-17 120 g in 1 BOTTLE
18 NDC:57817-300-18 150 g in 1 BOTTLE
19 NDC:57817-300-19 180 g in 1 BOTTLE
20 NDC:57817-300-20 200 g in 1 BOTTLE
21 NDC:57817-300-21 250 g in 1 BOTTLE
22 NDC:57817-300-22 300 g in 1 BOTTLE
23 NDC:57817-300-23 2 g in 1 PACKAGE
24 NDC:57817-300-23 2 g in 1 PACKAGE
25 NDC:57817-300-24 3 g in 1 PACKAGE
26 NDC:57817-300-25 4 g in 1 PACKAGE
27 NDC:57817-300-26 5 g in 1 PACKAGE
28 NDC:57817-300-27 6 g in 1 PACKAGE
29 NDC:57817-300-28 7 g in 1 PACKAGE
30 NDC:57817-300-29 8 g in 1 PACKAGE
31 NDC:57817-300-30 9 g in 1 PACKAGE
32 NDC:57817-300-31 10 g in 1 PACKAGE
33 NDC:57817-300-32 12 g in 1 PACKAGE
34 NDC:57817-300-33 15 g in 1 PACKAGE
35 NDC:57817-300-34 20 g in 1 PACKAGE
36 NDC:57817-300-35 25 g in 1 PACKAGE
37 NDC:57817-300-36 30 g in 1 PACKAGE
38 NDC:57817-300-37 35 g in 1 PACKAGE
39 NDC:57817-300-38 40 g in 1 PACKAGE
40 NDC:57817-300-39 45 g in 1 PACKAGE
41 NDC:57817-300-40 50 g in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/18/2013
Labeler - Hangzhou Haorun Technology CO.,LTD. (421308583)
Establishment
Name Address ID/FEI Business Operations
Hangzhou Haorun Technology CO.,LTD. 421308583 manufacture(57817-300)

Revised: 3/2013
Document Id: 3f1e61d0-49ea-4d8d-ae28-7de4c24ae086
Set id: 61f3635d-3d95-4387-a48c-45d6c7479857
Version: 1
Effective Time: 20130330
 
Hangzhou Haorun Technology CO.,LTD.