Label: SHEER PROTECTION SPF 30- zinc oxide cream

  • NDC Code(s): 83657-610-03, 83657-610-08, 83657-610-63
  • Packager: Skin Script, LLC
  • 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 September 7, 2023

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient(s): Zinc Oxide (13.5%)

  • PURPOSE

    Purpose: Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children. If the product is swallowed, get medical help or contact a Posion Control center right away.
  • INDICATIONS & USAGE

    Uses:

    • Helps prevent sunburn
    • If used as directed with other protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • WARNINGS

    Warnings:

    • For external use only.
    • Do not use on damaged or broken skin.
    • When using this product keep out of eyes. Rinse with water to remove.
    • Stop use and ask a doctor if rash occurs.
    • Keep out of reach of children. If the product is swallowed, get medical help or contact a Posion Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions:

    • Apply liberally 15 min before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours
    • Children under 6 months: Ask a doctor.
    • 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 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm. Wear long sleeve shirts, pants, hats, and sunglasses.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Aqua (Water), Caprylic/Capric Triglyceride, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glycerin, Isodecyl Neopentanoate, Ethyl Macadamiate, Aleurites Moluccanus Seed Oil, Hydroxypropyl Starch Phosphate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Ergothioneine (L), Hordeum Distichon (Barley) Extract, Macadamia Ternifolia Seed Oil, Porphyra Umbilicalis (Red Algae) Extract, Santalum Album (Sandalwood) Extract, Phellodendron Amurense Bark Extract, Bisabolol (L-alpha), Glyceryl Isostearate, Sodium Stearoyl Lactylate, Polyglyceryl-10 Pentastearate, Polyhydroxystearic Acid, Tocopheryl Acetate (D-alpha), Tocopherol (D-alpha), Lecithin, Malic Acid (L), Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Alcohol, Cetearyl Alcohol, Behenyl Alcohol, Hydroxypropyl Methylcellulose, Sodium Lactate, Phytic Acid, Citric Acid, Sodium Hydroxide

  • OTHER SAFETY INFORMATION

    Other Information:

    • Protect the product from excessive heat and direct sun.
  • PRINCIPAL DISPLAY PANEL

    PDP

  • INGREDIENTS AND APPEARANCE
    SHEER PROTECTION SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83657-610
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0135 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    PEG-60 GLYCERYL STEARATE (UNII: 85O35YN6YY)  
    PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    ALCOHOL (UNII: 3K9958V90M)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    SANDALWOOD (UNII: 3641YW25N2)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    BARLEY (UNII: 5PWM7YLI7R)  
    HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    ALEURITES MOLUCCANA SEED (UNII: J87WJ3E7VW)  
    POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
    MALIC ACID, L- (UNII: J3TZF807X5)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83657-610-0360 g in 1 TUBE; Type 0: Not a Combination Product01/01/2012
    2NDC:83657-610-087.5 g in 1 JAR; Type 0: Not a Combination Product01/01/2012
    3NDC:83657-610-637 g in 1 TUBE; Type 0: Not a Combination Product01/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02001/01/2012
    Labeler - Skin Script, LLC (050951910)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!