SUNSCREEN SPF30- sunscreen spf30 liquid 
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

PEG-100 STEARATE------------ Sunscreen SPF30

TITANIUM DIOXIDE

ETHYLHEXYL METHOXYCINNAMATE

BUTYL METHOXYDIBENZOYLMETHANE

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. Keep 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 15 minutes before sun exposure and reapply as need.

Children under 6 months: ask a doctor before use.

Inactive Ingredients:

MINERAL OIL, SILICON, 4-HYDROXYBENZOIC ACID, PROPYL ACETATE, MONOGLYCERIDE CITRATE, GETOSTEARYL ALCOHOL, SODIUM DODECYLBENZENESULFONATE, CYCLOMETHICONE, ETHYLENE GLYCOL, WATER, XANTHAN GUM, CARBOMER 940, ALLANTOIN, GLYCERIN, 1,2-BUTANEDIOL, GPL

image of sunscreen spf 30

SUNSCREEN SPF30 
sunscreen spf30 liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-216
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PEG-100 STEARATE (UNII: YD01N1999R) (PEG-100 STEARATE - UNII:YD01N1999R) PEG-100 STEARATE2.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4 g  in 100 g
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) (ETHYLHEXYL METHOXYCRYLENE - UNII:S3KFG6Q5X8) ETHYLHEXYL METHOXYCRYLENE1.25 g  in 100 g
BENZOPHENONE (UNII: 701M4TTV9O) (BENZOPHENONE - UNII:701M4TTV9O) BENZOPHENONE0.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.75 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP) 5 g  in 100 g
SILICON (UNII: Z4152N8IUI) 1 g  in 100 g
4-HYDROXYBENZOIC ACID (UNII: JG8Z55Y12H) 0.2 g  in 100 g
PROPYL ACETATE (UNII: 4AWM8C91G6) 0.1 g  in 100 g
GLYCERYL MONOOLEATE CITRATE (UNII: NLE5KIG74K) 1.5 g  in 100 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 2 g  in 100 g
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y) 5 g  in 100 g
CYCLOMETHICONE (UNII: NMQ347994Z) 2 g  in 100 g
ETHYLENE GLYCOL (UNII: FC72KVT52F) 0.8 g  in 100 g
WATER (UNII: 059QF0KO0R) 59.7 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE) 0.25 g  in 100 g
CARBOMER 940 (UNII: 4Q93RCW27E) 10 g  in 100 g
ALLANTOIN (UNII: 344S277G0Z) 0.3 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 100 g
1,2-BUTANEDIOL (UNII: RUN0H01QEU) 3 g  in 100 g
DMDM HYDANTOIN (UNII: BYR0546TOW) 0.15 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47993-216-0110 g in 1 TUBE; Type 0: Not a Combination Product06/01/2015
2NDC:47993-216-0215 g in 1 TUBE; Type 0: Not a Combination Product06/01/2015
3NDC:47993-216-0320 g in 1 TUBE; Type 0: Not a Combination Product06/01/2015
4NDC:47993-216-0430 g in 1 TUBE; Type 0: Not a Combination Product06/01/2015
5NDC:47993-216-0550 g in 1 TUBE; Type 0: Not a Combination Product06/01/2015
6NDC:47993-216-0660 g in 1 TUBE; Type 0: Not a Combination Product06/01/2015
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(47993-216)

Revised: 1/2018
Document Id: 63098fb5-2144-79dd-e053-2a91aa0a1ad7
Set id: c16e8c37-6773-4fc9-9ea8-bda005742988
Version: 4
Effective Time: 20180118
 
NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD