Label: SPF 30 MINERAL SUNSCREEN FACE NECK- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 11, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients: Zinc Oxide - 18.6%

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Uses:

    • High protection against sunburn.
    • Higher SPF gives more sunburn protection.
    • 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 10am - 2pm.
    • Wear long sleeved shirts, pants, hats and sunglasses.
  • WARNINGS

    Warnings: For external use only.

  • WHEN USING

    When using this product keep out of eyes.Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs. Do not use on damaged or broken skin.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    Directions:

    • Apply generously 15 minutes before su exposure.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply as needed or after towel drying, swimming or perspiring.
    • Children under 6 months of age: ask a doctor.
  • OTHER SAFETY INFORMATION

    Other Information

    • Sun Alert: limiting sun exposure, wearing protective clothing and using sunscreen may reduce the risk of skin aging, skin cancer and other harmful effects of the sun.
  • STORAGE AND HANDLING

    Protect the product in this container from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Dimethicone, Cetyl Alcohol, Caprylic/Capric Triglyceride, Organic Butyrospermum Parkii (Shea) Butter, Polyacrylamide, C13-14 Isoparaffin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Tocopheryl Linoleate/Oleate, Physalis Angulata Extract, Teprenone, Leontopodium Alpinum Meristem Cell Culture, Polygonum Aviculare Extract, Imperata Cylindrica Root Extract, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Organic Camellia Sinensis Leaf Extract, Phoenix Dactylifera (Date) Fruit Extract, Sidium Lactete, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Organic Aloe Barbadensis Leaf Juice, Lecithin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate-20, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Laureth-7, Xanthan Gum, Carbomer, PEG-8, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Disodium EDTA.

  • PRINCIPAL DISPLAY PANEL

    Made in USA

    Distributed by OJAS, LLC

    OjasSkin.com

    Faceneck2ml

    Faceneck50ml

  • INGREDIENTS AND APPEARANCE
    SPF 30 MINERAL SUNSCREEN FACE NECK 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4086
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION186 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
    TEPRENONE (UNII: S8S8451A4O)  
    LEONTOPODIUM ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
    ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    PHOENIX RECLINATA FRUIT (UNII: B140O227ZE)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    LAURETH-7 (UNII: Z95S6G8201)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4086-12 mL in 1 TUBE; Type 0: Not a Combination Product07/14/2016
    2NDC:62742-4086-31 in 1 CARTON07/14/2016
    2NDC:62742-4086-250 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/11/2016
    Labeler - Allure Labs Inc (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs Inc926831603manufacture(62742-4086)