Label: UNIWELL AQUA SUNCREAM- octinoxate, octisalate cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 71502-001-01, 71502-001-02 - Packager: uniwell LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 June 12, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
DOSAGE & ADMINISTRATION
Apply liberally 15 minutes before sun exposure.
Reapply at least every two hours
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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months - WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
INACTIVE INGREDIENT
Water, Butylene Glycol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, C12-15 Alkyl Benzoate, Niacinamide, Methyl Methacrylate Crosspolymer, Phenylbenzimidazole Sulfonic Acid, Cetearyl Alcohol, Glyceryl Stearate, Cetearyl Olivate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Sorbitan Olivate, Polysorbate 60, PEG-100 Stearate, Sorbitan Stearate, Dimethicone, Polyacrylate-13, Panthenol, Caprylyl Glycol, Sodium Hydroxide, Polyisobutene, Ethylhexylglycerin, Citrus Aurantium Dulcis (Orange) Oil, 1,2-Hexanediol, Disodium EDTA, Propolis Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Camellia Sinensis Leaf Extract, Lavandula Angustifolia (Lavender) Oil, Adenosine, Polysorbate 20, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Sorbitan Isostearate, Panax Ginseng Root Extract, Portulaca Oleracea Extract, Ecklonia cava Extract, Codium Tomentosum Extract, Gelidium Cartilagineum Extract, Hizikia Fusiforme Extract, Glycerin, Geranium Maculatum Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Santalum Album (Sandalwood) Oil, Rose Flower Oil, Chamomilla Recutita (Matricaria) Flower Oil, Olea Europaea (Olive) Leaf Extract, Alcohol, Anthemis Nobilis Flower Extract, Brassica Oleracea Italica (Broccoli) Extract, Phenoxyethanol, Styrax Benzoin Gum, Commiphora Myrrha Oil, Aloe Barbadensis Leaf Juice, Gossypium Herbaceum (Cotton) Extract, Potassium sorbate, Sodium Benzoate
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
UNIWELL AQUA SUNCREAM
octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71502-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 3.5 mg in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.25 mg in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) NIACINAMIDE (UNII: 25X51I8RD4) ENSULIZOLE (UNII: 9YQ9DI1W42) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Cetearyl Olivate (UNII: 58B69Q84JO) BEMOTRIZINOL (UNII: PWZ1720CBH) Sorbitan Olivate (UNII: MDL271E3GR) Polysorbate 60 (UNII: CAL22UVI4M) PEG-100 Stearate (UNII: YD01N1999R) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) DIMETHICONE (UNII: 92RU3N3Y1O) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) Panthenol (UNII: WV9CM0O67Z) Caprylyl Glycol (UNII: 00YIU5438U) Sodium Hydroxide (UNII: 55X04QC32I) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) Ethylhexylglycerin (UNII: 147D247K3P) ORANGE OIL (UNII: AKN3KSD11B) 1,2-Hexanediol (UNII: TR046Y3K1G) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PROPOLIS WAX (UNII: 6Y8XYV2NOF) LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P) GREEN TEA LEAF (UNII: W2ZU1RY8B0) LAVENDER OIL (UNII: ZBP1YXW0H8) ADENOSINE (UNII: K72T3FS567) POLYSORBATE 20 (UNII: 7T1F30V5YH) HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) ASIAN GINSENG (UNII: CUQ3A77YXI) PURSLANE (UNII: M6S840WXG5) ECKLONIA CAVA (UNII: UXX2N5V39P) CODIUM TOMENTOSUM (UNII: B8B45BRU87) GELIDIUM CARTILAGINEUM (UNII: 37LBZ0E1UE) SARGASSUM FUSIFORME (UNII: X436TJ4A11) Glycerin (UNII: PDC6A3C0OX) GERANIUM MACULATUM ROOT OIL (UNII: H2E371EDYX) BERGAMOT OIL (UNII: 39W1PKE3JI) SANDALWOOD OIL (UNII: X7X01WMQ5F) ROSA RUGOSA FLOWER BUD (UNII: TZ0BE8I3MW) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) Alcohol (UNII: 3K9958V90M) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) PHENOXYETHANOL (UNII: HIE492ZZ3T) STYRAX BENZOIN RESIN (UNII: FE663Z8IRO) MYRRH OIL (UNII: H74221J5J4) ALOE VERA LEAF (UNII: ZY81Z83H0X) LEVANT COTTON SEED (UNII: 550E4N439V) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71502-001-02 1 in 1 CARTON 06/12/2017 1 NDC:71502-001-01 50 mL in 1 CONTAINER; 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 06/12/2017 Labeler - uniwell LTD (694646565) Registrant - uniwell LTD (694646565) Establishment Name Address ID/FEI Business Operations Cosmecca Korea Co., Ltd. 688830827 manufacture(71502-001)
