Label: REEF REPAIR SPF 30 SUNCREAM- zinc oxide, 20% cream

  • NDC Code(s): 73541-001-01
  • Packager: Alive 2 Dive Company Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 7, 2024

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

  • ACTIVE INGREDIENT

    Active ingredient

    Zinc Oxide, 20%

  • PURPOSE

    Purpose

    Sunscreen

  • Uses

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

    For external use only

    keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

    Do not use

    Do not use on damaged or broken skin

    Stop use and ask a doctor if

    Stop use and ask a doctor if rash occurs

    When using this product

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

  • Directions

    • Apply liberally and evenly to dry skin 15 minutes before sun exposure
    • Apply to all skin exposed to the sun
    • Apply to dry skin
    • Children under 6 months of age: Ask a doctor
    • Reapply: aAfter 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours
    • Sun Proctection Measures: Spending time in the sun increases your risk of skin cance and early skin aging. To decrease this risk, regularly use a sunscreen with a Broas Spectrum SPF calue 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

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aqua, Cocos nuciera (Coconut oil), Persea gratissma (Avocado oil), Cetearyl alcohol / Polysorbate 60 (Vegatable emulsifying wax NF), Butyrospernum parkii (Shea butter), Rubus idaeus (Red Raspberry seed oil), Glyceryl Oleate Citrate & Caprylic / Capric Triglyceride, Glycerin, Cera alba (Beeswax), Ethylhexylglycerin & Propanediol, Polyhydoxystearic acid, Sodium Gluconate, Cocos nucifera (Coconut essential oil), Vanilla plantifolia (Vanilla essential oil)

  • Other Information

    • Protect the product in this container from excessive heat and direct sun
    • 100% biodegradable non-toxic, reef safe formula
    • Contains no harmful chemicals, parabens or silicones
    • Broad Spectrum SPF 30+
    • PA+++
    • Moisturizing
    • Cruetly free (Not tested on animals)
    • Water resistant (80 Minutes)
  • label

    label

  • INGREDIENTS AND APPEARANCE
    REEF REPAIR SPF 30  SUNCREAM
    zinc oxide, 20% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73541-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    VANILLA PLANIFOLIA OIL (UNII: 0A3F415158)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    GLYCERYL MONOOLEATE CITRATE (UNII: NLE5KIG74K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73541-001-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product12/27/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/27/2019
    Labeler - Alive 2 Dive Company Limited (662332223)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alive 2 Dive Company Limited662332223manufacture(73541-001)