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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57817-300
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE6 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE4 g  in 100 g
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
Glycerin 
Tocopherol 
WATER 
POLYSORBATE 20 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57817-300-0110 g in 1 BOTTLE
2NDC:57817-300-0212 g in 1 BOTTLE
3NDC:57817-300-0315 g in 1 BOTTLE
4NDC:57817-300-0420 g in 1 BOTTLE
5NDC:57817-300-0525 g in 1 BOTTLE
6NDC:57817-300-0630 g in 1 BOTTLE
7NDC:57817-300-0735 g in 1 BOTTLE
8NDC:57817-300-0840 g in 1 BOTTLE
9NDC:57817-300-0945 g in 1 BOTTLE
10NDC:57817-300-1050 g in 1 BOTTLE
11NDC:57817-300-1160 g in 1 BOTTLE
12NDC:57817-300-1270 g in 1 BOTTLE
13NDC:57817-300-1380 g in 1 BOTTLE
14NDC:57817-300-1490 g in 1 BOTTLE
15NDC:57817-300-15100 g in 1 BOTTLE
16NDC:57817-300-16110 g in 1 BOTTLE
17NDC:57817-300-17120 g in 1 BOTTLE
18NDC:57817-300-18150 g in 1 BOTTLE
19NDC:57817-300-19180 g in 1 BOTTLE
20NDC:57817-300-20200 g in 1 BOTTLE
21NDC:57817-300-21250 g in 1 BOTTLE
22NDC:57817-300-22300 g in 1 BOTTLE
23NDC:57817-300-232 g in 1 PACKAGE
24NDC:57817-300-232 g in 1 PACKAGE
25NDC:57817-300-243 g in 1 PACKAGE
26NDC:57817-300-254 g in 1 PACKAGE
27NDC:57817-300-265 g in 1 PACKAGE
28NDC:57817-300-276 g in 1 PACKAGE
29NDC:57817-300-287 g in 1 PACKAGE
30NDC:57817-300-298 g in 1 PACKAGE
31NDC:57817-300-309 g in 1 PACKAGE
32NDC:57817-300-3110 g in 1 PACKAGE
33NDC:57817-300-3212 g in 1 PACKAGE
34NDC:57817-300-3315 g in 1 PACKAGE
35NDC:57817-300-3420 g in 1 PACKAGE
36NDC:57817-300-3525 g in 1 PACKAGE
37NDC:57817-300-3630 g in 1 PACKAGE
38NDC:57817-300-3735 g in 1 PACKAGE
39NDC:57817-300-3840 g in 1 PACKAGE
40NDC:57817-300-3945 g in 1 PACKAGE
41NDC:57817-300-4050 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/18/2013
Labeler - Hangzhou Haorun Technology CO.,LTD. (421308583)
Establishment
NameAddressID/FEIBusiness Operations
Hangzhou Haorun Technology CO.,LTD. 421308583manufacture(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.