Label: PRO-COLLAGEN MARINE BROAD SPECTRUM SPF 30- avobenzone, octinoxate, and octocrylene cream

  • NDC Code(s): 65912-001-10, 65912-001-11, 65912-001-15, 65912-001-16, view more
    65912-001-30, 65912-001-31, 65912-001-50, 65912-001-51, 65912-001-52, 65912-001-53
  • Packager: ELEMIS Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone 1.0% }
    Octinoxate 1.0%}
    Octocrylene 0.5%}

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
  • 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally and evenly 15 minutes before sun exposure and as needed
    • children under 6 months of age: Ask a doctor
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin ageing. 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 10 a.m. - 2 p.m.
      • wear long-sleeved shirts, pants, hats, and sunglasses
      • reapply at least every 2 hours
      • use a water resistant sunscreen if swimming or sweating
  • Other information

    • protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    AQUA/WATER/EAU
    GLYCERIN
    CAPRYLIC/CAPRIC TRIGLYCERIDE
    GLYCERYL STEARATE SE
    ISONONYL ISONONANOATE
    DICAPRYLYL CARBONATE
    DIMETHICONE
    BUTYL METHOXYDIBENZOYLMETHANE
    ETHYLHEXYL METHOXYCINNAMATE
    PHENOXYETHANOL
    POLYACRYLATE-13
    BUTYLENE GLYCOL
    CETYL ALCOHOL
    HYDROXYACETOPHENONE
    STEARIC ACID
    TOCOPHERYL ACETATE
    COCO-CAPRYLATE
    XANTHAN GUM
    CHLORPHENESIN
    POLYISOBUTENE
    FRAGRANCE (PARFUM)
    DISODIUM EDTA
    TOCOPHEROL
    BUTYROSPERMUM PARKII (SHEA)
    BUTTER
    TRITICUM VULGARE (WHEAT) GERM OIL
    CHLORELLA VULGARIS EXTRACT
    GLYCERYL POLYACRYLATE
    DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT
    GLYCERYL ACRYLATE/ACRYLIC ACID COPOLYMER
    LECITHIN
    PADINA PAVONICA THALLUS EXTRACT
    SODIUM DEHYDROACETATE
    POLYSORBATE 20
    SORBITAN ISOSTEARATE
    GINKGO BILOBA LEAF EXTRACT
    INGREDIENT NAME
    PORPHYRIDIUM CRUENTUM EXTRACT
    MIMOSA TENUIFLORA BARK EXTRACT
    ROSA DAMASCENA FLOWER
    EXTRACT
    COLLAGEN AMINO ACIDS
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE
    POTASSIUM SORBATE
    SODIUM BENZOATE
    CITRIC ACID

  • Questions?

    US T: 1-855-235-3647

  • PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

    Pro-Collagen Marine

  • INGREDIENTS AND APPEARANCE
    PRO-COLLAGEN MARINE  BROAD SPECTRUM SPF 30
    avobenzone, octinoxate, and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65912-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE10 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE10 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    WHEY PROTEIN HYDROLYSATE (UNII: 237DZG2JLA)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CARROT (UNII: L56Z1JK48B)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    PADINA PAVONICA (UNII: 177U06NHZI)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    GINKGO (UNII: 19FUJ2C58T)  
    PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N)  
    ACACIA DECURRENS FLOWER (UNII: 8PHF3LSM61)  
    ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65912-001-501 in 1 CARTON01/19/2018
    150 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:65912-001-151 in 1 CARTON01/19/2018
    215 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:65912-001-5150 g in 1 JAR; Type 0: Not a Combination Product01/19/2018
    4NDC:65912-001-532 in 1 CARTON09/01/2019
    450 g in 1 JAR; Type 1: Convenience Kit of Co-Package
    5NDC:65912-001-301 in 1 CARTON07/31/2020
    530 g in 1 JAR; Type 0: Not a Combination Product
    6NDC:65912-001-3130 g in 1 JAR; Type 0: Not a Combination Product07/31/2020
    7NDC:65912-001-101 in 1 CARTON09/01/2021
    7100 g in 1 JAR; Type 0: Not a Combination Product
    8NDC:65912-001-11100 g in 1 JAR; Type 0: Not a Combination Product09/01/2021
    9NDC:65912-001-5250 g in 1 JAR; Type 0: Not a Combination Product01/19/2018
    10NDC:65912-001-1615 g in 1 TUBE; Type 0: Not a Combination Product01/19/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/19/2018
    Labeler - ELEMIS Limited (399838895)
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