SUNSCREEN- octinoxate,oxybenzone,octisalate,titanium dioxide lotion
Yuyao Jessie Commodity 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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51414-906 Sunscreen Lotion

Active Ingredient

Octinoxate 7%
oxybenzone 3.0%
Octisalate 4%

Titanium dioxide 4%

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

Skin Cancer /Skin Aging Alert:spending time in the sun increases your risk of skin cancer and early skin aging.This product has been shown only to hel prevent sunbum .not skin cancer or early skin aging.

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 and as needed.

use a water resistant sunscreen if swimming or sweating.

reaplly at least every 2 hours.

children under 6 months ,ask a doctor.

Inactive ingredients

C12-15 Alkyl benzoate ,isopropyl myristate ,caprylic/capric triglyceride,cetearyl alcohol,cetheh-25,glyceryl stearate,glycerin,dmdh hydantoin,metyl paraben,proplyparaben,cyclomethicone,fragance,water(aqua)

lebel

SUNSCREEN
octinoxate,oxybenzone,octisalate,titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51414-906
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4 g in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CETETH-25 (UNII: 5KLY4IOG20)
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
METHYLPARABEN (UNII: A2I8C7HI9T)
CYCLOMETHICONE (UNII: NMQ347994Z)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51414-906-01	5 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
2	NDC:51414-906-02	8 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
3	NDC:51414-906-03	10 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
4	NDC:51414-906-04	15 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
5	NDC:51414-906-05	20 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
6	NDC:51414-906-06	30 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
7	NDC:51414-906-07	40 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
8	NDC:51414-906-08	50 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
9	NDC:51414-906-09	60 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
10	NDC:51414-906-10	80 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
11	NDC:51414-906-11	90 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
12	NDC:51414-906-12	100 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
13	NDC:51414-906-13	120 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
14	NDC:51414-906-14	150 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
15	NDC:51414-906-15	200 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
16	NDC:51414-906-16	240 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
17	NDC:51414-906-17	300 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
18	NDC:51414-906-18	360 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
19	NDC:51414-906-19	400 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016
20	NDC:51414-906-20	500 g in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2016

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Yuyao Jessie Commodity Co.,Ltd.		529892305	manufacture(51414-906)

Revised: 3/2022

Document Id: da8b491b-bc8b-a5b1-e053-2a95a90acfad

Set id: 68df3526-19c2-3ce1-e053-2991aa0aee32

Version: 3

Effective Time: 20220318

Yuyao Jessie Commodity Co.,Ltd.