GIN-III ALPHA AND OMEGA GIN SUN- zinc oxide, titanium dioxide cream 
Hanwool Life Sciences. 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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GIN-III Alpha and Omega GIN Sun Cream

Active Ingredients

Zinc Oxide (4%)

Titanium Dioxide (1.6%)

Purpose

Sunscreen

Keep out of reach of children

 Do not swallow. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Warnings

For external use only
Do not use on damaged or broken skin
When using this product
 Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Stop use and ask doctor if rash or irritation on skin develops and lasts.

 Store at room temperature

Directions

Apply the adequate amount on the palm of the hands and pat lightly with the fingertips.
• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
 Limit time in the sun, especially from 10 a.m. - 2 p.m.
 Wear long-sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months of age: ask a doctor

Uses

Helps prevent sunburn

Inactive Ingredients

Water, Ethylhexyl Methoxycinnamate, Dipropylene Glycol, Butylene Glycol, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Ethylhexyl Salicylate, Isoamyl p-Methoxycinnamate, Niacinamide, Cyclomethicone, Cyclopentasiloxane, Cyclohexasiloxane, Dicaprylyl Carbonate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Polysorbate 60, Butyl Methoxydibenzoylmethane, Cetearyl Olivate, Sorbitan Stearate, Sorbitan Olivate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Polyacrylate-13, Silica, Polyisobutene, Usnea Barbata (Lichen) Extract, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Fragrance (Parfum), Triethoxycaprylylsilane, Ginsenosides, Xanthan Gum, Saponins, Caprylyl Glycol, Disodium EDTA, Adenosine, Dimethicone, Polysorbate 20, 1,2-Hexanediol, Propanediol, Illicium Verum (Anise) Fruit Extract, Lavandula Angustifolia (Lavender) Extract, Rosmarinus Officinalis (Rosemary) Extract, Aspalathus Linearis Extract, Thymus Vulgaris (Thyme) Extract, Salvia Officinalis (Sage) Extract, Aloe Barbadensis Leaf Juice, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Eucalyptus Globulus Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Symphytum Officinale Leaf Extract

GIN-III Alpha and Omega GIN Sun Cream

suncream

GIN-III ALPHA AND OMEGA GIN SUN 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71135-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.8 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
OCTINOXATE (UNII: 4Y5P7MUD51)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
Butylene Glycol (UNII: 3XUS85K0RA)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
OCTISALATE (UNII: 4X49Y0596W)  
AMILOXATE (UNII: 376KTP06K8)  
Niacinamide (UNII: 25X51I8RD4)  
Cyclomethicone (UNII: NMQ347994Z)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
Polysorbate 60 (UNII: CAL22UVI4M)  
AVOBENZONE (UNII: G63QQF2NOX)  
Cetearyl Olivate (UNII: 58B69Q84JO)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
USNEA BARBATA (UNII: D6DVA9TCAP)  
ZANTHOXYLUM PIPERITUM FRUIT PULP (UNII: 7PFC2VA251)  
PULSATILLA KOREANA ROOT (UNII: FY35I16MPL)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
GINSENOSIDES (UNII: 3K198YD54P)  
Xanthan Gum (UNII: TTV12P4NEE)  
Caprylyl Glycol (UNII: 00YIU5438U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Adenosine (UNII: K72T3FS567)  
Dimethicone (UNII: 92RU3N3Y1O)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
Propanediol (UNII: 5965N8W85T)  
STAR ANISE FRUIT (UNII: CK15HA8438)  
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
ROSEMARY (UNII: IJ67X351P9)  
ASPALATHUS LINEARIS WHOLE (UNII: O17JQA1A9Z)  
THYME (UNII: CW657OBU4N)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
CHAMOMILE (UNII: FGL3685T2X)  
COMFREY LEAF (UNII: DG4F8T839X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71135-100-021 in 1 PACKAGE12/12/2016
1NDC:71135-100-0150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/12/2016
Labeler - Hanwool Life Sciences. Co., Ltd (557789808)
Registrant - Hanwool Life Sciences. Co., Ltd (557789808)
Establishment
NameAddressID/FEIBusiness Operations
Hanwool Life Sciences. Co., Ltd557789808manufacture(71135-100)

Revised: 12/2016
Document Id: 4a487490-8c80-420a-a319-e91f41f1bb7d
Set id: d2fbca70-6cef-46fa-be96-faa64860b98c
Version: 2
Effective Time: 20161228
 
Hanwool Life Sciences. Co., Ltd