Label: GIN-III ALPHA AND OMEGA GIN SUN- zinc oxide, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71135-100-01, 71135-100-02 - Packager: Hanwool Life Sciences. Co., Ltd
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 28, 2016
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Keep out of reach of children
- Warnings
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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
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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
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INGREDIENTS AND APPEARANCE
GIN-III ALPHA AND OMEGA GIN SUN
zinc oxide, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71135-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 2 g in 50 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.8 g in 50 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:71135-100-02 1 in 1 PACKAGE 12/12/2016 1 NDC:71135-100-01 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/12/2016 Labeler - Hanwool Life Sciences. Co., Ltd (557789808) Registrant - Hanwool Life Sciences. Co., Ltd (557789808) Establishment Name Address ID/FEI Business Operations Hanwool Life Sciences. Co., Ltd 557789808 manufacture(71135-100)