SUNSCREEN- oxybenzone,octinoxate,octisalate lotion
NingBo Huize 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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71011-004 sunscreen

Active Ingredients

Octinoxate 7.5%,Octisalate 2.0%,Oxybenzone 4.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn

WARNINGS:

Skin Cancer/Skin Aging Alert: Spending time in the sun increase your risk of skin cancer and early skin aging. This products has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only. Do not use 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply generously & evenly before sun exposure.Reapply as needed or after towel drying, swimming, or sweating. Ask doctor before using on children under 6 months.

Inactive ingredients

Water, Stearic acid , Hexadecan-1-ol, Lanolin , Mineral oil, Glyceryl Stearate, POLYSORBATE80, Sorbitan Stearate,Glycerin,DMDM Hydantoin,Frangrance

SUNSCREEN
oxybenzone,octinoxate,octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71011-004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 g in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
DMDM HYDANTOIN (UNII: BYR0546TOW)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
HEXADECANAL (UNII: WQD27655QE)
MINERAL OIL (UNII: T5L8T28FGP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71011-004-01	100 in 1 BOX	07/18/2018
1		30 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/18/2018

Labeler - NingBo Huize Commodity Co.,Ltd. (544434795)

Registrant - NingBo Huize Commodity Co.,Ltd. (544434795)

Name	Address	ID/FEI	Business Operations
Establishment
NingBo Huize Commodity Co.,Ltd.		544434795	manufacture(71011-004)