SPF 30 SUNSCREEN- octinoxate oxybenzone octisalate spray

SPF 30 Sunscreen by

Drug Labeling and Warnings

SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Hangzhou Haorun Technology CO.,LTD. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPF 30 SUNSCREEN 
octinoxate oxybenzone octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57817-300
Route of Administration	TOPICAL

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)