SUN BLOCK SPRARY- sun block sprary spf15 spray 
NINGBO JIANGBEI OCEAN STAR TRADING 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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Active Ingredients

Active ingredients--------------purpose

HOMOSALATE 3%------------Sunscreen SPF15

OCTINOXATE 6%

Uses:

help prevent sunburn

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 prevent sunburn, not skin cancer or early skin aging. For external use only. Kepp out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed: seek medical help or contact a poison control center right away.

Directions:

Apply liberally 15mintues before sun exposure and reapply as needed.

Children under 6 months: ask a doctor before use.

Inactive Ingredients:

PROPYLENE GLYCOL, CYCLOMETHICONE, PEG-40 CASTOR OIL, SODIUM HYDROXIDE, CARBOMER 1342, METHYLPARABEN, IODOPROPYNYL BUTYLCARBAMATE, DISODIUM EDTA-COPPER, WATER

image of sun block lotion

SUN BLOCK SPRARY 
sun block sprary spf15 spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-215
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z) 6 g  in 100 g
PEG-40 CASTOR OIL (UNII: 4ERD2076EF) 1 g  in 100 g
DISODIUM EDTA-COPPER (UNII: 6V475AX06U) 0.03 g  in 100 g
CARBOMER 1342 (UNII: 809Y72KV36) 0.2 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 8 g  in 100 g
SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.5 g  in 100 g
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) 0.07 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T) 0.15 g  in 100 g
WATER (UNII: 059QF0KO0R) 75.05 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47993-215-0110 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
2NDC:47993-215-0215 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
3NDC:47993-215-0330 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
4NDC:47993-215-0560 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
5NDC:47993-215-0680 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
6NDC:47993-215-08100 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/20/2015
Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
Establishment
NameAddressID/FEIBusiness Operations
NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.,LTD544493972manufacture(47993-215)

Revised: 10/2019
Document Id: 9579e8e7-6ab1-57ba-e053-2a95a90afd34
Set id: 9b67cc89-2696-4759-af1e-5bd21f83f98b
Version: 6
Effective Time: 20191022
 
NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD