SPF30 SUNSCREEN- octinoxate,oxybenzone,octisalate spray

SPF30 sunscreen by

Drug Labeling and Warnings

SPF30 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 7.5%

oxybenzone 4.0%

Octisalate 4.0%

Purpose

Sunscreen

Use

hellps prevent sunburn.

if used as directed with other sun protection measures(see Dirctions),decreases the rish of skin cancer and early skin aging carsed by the sun

WARNINGS

For External use only.
Do not us on damaged or broken skin.

when using this product keep out of eyes,rinse with water to remove.

stop use and ask a doctor,if rash occurs.

keep out of reach of children

if product is swallowed,get medical help or contact a Poison Control Center right away.

Directions

apply liverally 15 minutes before sun exposure.

reapply

afgter 40 minutes of swimming or sweating.

immediately afger towel drying

at least eaery 2 hours.

Sun Portection Measure,Spending time in the sun increases your risk of skin cancer and early skin aging.To decrease this risk,regularly use a suncream with a broad spectrun SPF of 15 higher and other sun protection measures induding :

limit time in the sun especially from10 am -2pm

wear long -sleeve shirts ,pants,hats,and sunglasses

children under 6 months ,ask a doctor.

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

C12-15 Alkyl benzoate ,Titanium Dioxide,Carbomer ,Tricaprylin, Glycerol, Triethanolamine ,Propylene
Glycol ，Octyldodecanol，DMDM Hydantoin ， Fragance ，water

lebel

INGREDIENTS AND APPEARANCE

SPF30 SUNSCREEN 
octinoxate,oxybenzone,octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51414-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TRICAPRYLIN (UNII: 6P92858988)
CARBOMER 934 (UNII: Z135WT9208)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCEROL FORMAL (UNII: 3L7GR2604E)
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)
TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OCTYLDODECANOL (UNII: 461N1O614Y)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51414-104-01	5 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
2	NDC: 51414-104-02	7 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
3	NDC: 51414-104-03	8 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
4	NDC: 51414-104-04	10 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
5	NDC: 51414-104-05	12 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
6	NDC: 51414-104-06	15 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
7	NDC: 51414-104-07	20 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
8	NDC: 51414-104-08	25 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
9	NDC: 51414-104-09	30 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
10	NDC: 51414-104-10	40 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
11	NDC: 51414-104-11	50 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
12	NDC: 51414-104-12	60 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
13	NDC: 51414-104-13	70 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
14	NDC: 51414-104-14	80 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
15	NDC: 51414-104-15	90 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
16	NDC: 51414-104-16	100 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
17	NDC: 51414-104-17	120 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
18	NDC: 51414-104-18	130 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
19	NDC: 51414-104-19	150 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
20	NDC: 51414-104-20	160 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
21	NDC: 51414-104-21	180 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
22	NDC: 51414-104-22	200 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
23	NDC: 51414-104-23	220 g in 1 PACKAGE; Type 0: Not a Combination Product	12/12/2016
24	NDC: 51414-104-24	250 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016
25	NDC: 51414-104-25	300 g in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2016

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(51414-104)