SPF15 SUNSCREEN- octinoxate,oxybenzone,octisalate spray

SPF15 sunscreen by

Drug Labeling and Warnings

SPF15 sunscreen by is a Otc medication manufactured, distributed, or labeled by Yuyao Jessie Commodity Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SPF15 SUNSCREEN 
octinoxate,oxybenzone,octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51414-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 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: 51414-600-01	5 g in 1 PACKAGE; Type 0: Not a Combination Product	01/04/2018
2	NDC: 51414-600-02	7 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
3	NDC: 51414-600-03	8 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
4	NDC: 51414-600-04	10 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
5	NDC: 51414-600-05	12 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
6	NDC: 51414-600-06	15 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
7	NDC: 51414-600-07	20 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
8	NDC: 51414-600-08	25 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
9	NDC: 51414-600-09	30 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
10	NDC: 51414-600-10	40 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
11	NDC: 51414-600-11	50 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
12	NDC: 51414-600-12	60 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
13	NDC: 51414-600-13	70 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
14	NDC: 51414-600-14	80 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
15	NDC: 51414-600-15	90 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
16	NDC: 51414-600-16	100 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
17	NDC: 51414-600-17	120 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
18	NDC: 51414-600-18	130 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
19	NDC: 51414-600-19	150 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
20	NDC: 51414-600-20	160 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
21	NDC: 51414-600-21	180 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
22	NDC: 51414-600-22	200 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
23	NDC: 51414-600-23	220 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
24	NDC: 51414-600-24	250 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
25	NDC: 51414-600-25	300 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/12/2012

Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)

Establishment
Name	Address	ID/FEI	Business Operations
Yuyao Jessie Commodity Co.,Ltd.		529892305	manufacture(51414-600)