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 29, 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.
  • WARNINGS

    Warnings: For external use only.

  • WHEN USING

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

  • ASK DOCTOR

    Stop use ans ask a doctor if rash occurs.

  • DO NOT USE

    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 sun 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.
  • STORAGE AND HANDLING

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

  • INACTIVE INGREDIENTS

    Water (Aqua), Cycclopentasiloxane, 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, Polyaqcrylamide, 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, Sodium Lactate, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Organic Aloe Barbadensis Leaf Juice Powder, 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

    30030A-OJAS-SPF30FaceNeck-PROOF_cropped

  • INGREDIENTS AND APPEARANCE
    SPF 30 MINERAL SUNSCREEN FACE NECK 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70867-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
    TEPRENONE (UNII: S8S8451A4O)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ACTINIDIA CHINENSIS ROOT (UNII: 1L6O0O338I)  
    ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    ECHINACEA PURPUREA (UNII: QI7G114Y98)  
    PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
    LEONTOPODIUM ALPINUM FLOWER (UNII: MWN6IZU3XM)  
    ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    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:70867-104-521 in 1 CARTON07/26/2016
    1NDC:70867-104-1150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/26/2016
    Labeler - OJAS, LLC (080118329)
    Registrant - OJAS, LLC (080118329)