Label: FESTIVAL FAVORITES- avobenzone, octinoxate, and octocrylene kit

  • 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 August 9, 2021

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

  • 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

    Water, Glycerin, Caprylic/Capric Triglyceride, Glyceryl Stearate SE, Isononyl Isononanoate, Dicaprylyl Carbonate, Dimethicone, Phenoxyethanol, Polyacrylate-13, Butylene Glycol, Cetyl Alcohol, Hydroxyacetophenone, Stearic Acid, Tocopheryl Acetate, Coco-Caprylate, Xanthan Gum, Chlorphenesin, Polyisobutene, Fragrance, Disodium EDTA, Lecithin, Tocopherol, Butyrospermum Parkii (Shea) Butter, Daucus Carota Sativa (Carrot) Root Extract, Triticum Vulgare (Wheat) Germ Oil, Chlorella Vulgaris Extract, Glyceryl Polyacrylate, Glyceryl Acrylate/Acrylic Acid Copolymer, Padina Pavonica Thallus Extract, Sodium Dehydroacetate, Polysorbate 20, Sorbitan Isostearate, Ginkgo Biloba Leaf Extract, Porphyridium Cruentum Extract, Acacia Decurrens (Mimosa) Flower Extract, Rosa Centifolia (Rose) Flower Extract, Sodium Benzoate, Potassium Sorbate, Citric Acid.

  • Questions?

    US T: 1-855-235-3647

  • PRINCIPAL DISPLAY PANEL - Kit Bag

    ELEMIS

    FESTIVAL
    FAVORITES

    Protect & refresh
    with these festival-friendly
    skincare essentials.

    ELEMIS.COM

    @ELEMIS

    PRINCIPAL DISPLAY PANEL - Kit Bag
  • INGREDIENTS AND APPEARANCE
    FESTIVAL FAVORITES 
    avobenzone, octinoxate, and octocrylene kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65912-005
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65912-005-011 in 1 BAG03/15/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 30 g
    Part 21 TUBE 15 g
    Part 31 BOTTLE, SPRAY 100 g
    Part 1 of 3
    SUPERFOOD FACIAL WASH 
    cleansing (cold creams, cleansing lotions, liquids, and pads) soap
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRMETHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    INGRCHLORPHENESIN (UNII: I670DAL4SZ)  
    INGRCOCONUT WATER (UNII: 267F5Y81NT)  
    INGR.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
    INGRSODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    INGRORANGE OIL (UNII: AKN3KSD11B)  
    INGRAMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)  
    INGRPALMAROSA OIL (UNII: 0J3G3O53ST)  
    INGRGERANIOL (UNII: L837108USY)  
    INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
    INGRROSEMARY OIL (UNII: 8LGU7VM393)  
    INGRASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRCARROT SEED OIL (UNII: 595AO13F11)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRLEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic03/15/2019
    Part 2 of 3
    PRO-COLLAGEN MARINE SPF 30 
    avobenzone, octinoxate, and octocrylene cream
    Product Information
    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
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    115 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/15/2019
    Part 3 of 3
    SUPERFOOD KEFIR-TEA MIST 
    skin fresheners spray
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRBUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRSODIUM LACTATE (UNII: TU7HW0W0QT)  
    INGRCOCO GLUCOSIDE (UNII: ICS790225B)  
    INGRGLYCERYL OLEATE (UNII: 4PC054V79P)  
    INGRDICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    INGRLAURYL ALCOHOL (UNII: 178A96NLP2)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRAVOCADO OIL (UNII: 6VNO72PFC1)  
    INGRCHLORPHENESIN (UNII: I670DAL4SZ)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGR.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
    INGRBROCCOLI SEED OIL (UNII: SY01LVD4G4)  
    INGRPUMPKIN SEED OIL (UNII: 6E5QR5USSP)  
    INGRGALACTOARABINAN (UNII: SL4SX1O487)  
    INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    INGRCHIA SEED OIL (UNII: MC2LH51BO7)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    INGRORANGE OIL (UNII: AKN3KSD11B)  
    INGRSODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    INGRCARAMEL (UNII: T9D99G2B1R)  
    INGRAMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)  
    INGRPALMAROSA OIL (UNII: 0J3G3O53ST)  
    INGRGERANIOL (UNII: L837108USY)  
    INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
    INGRROSEMARY OIL (UNII: 8LGU7VM393)  
    INGRCARROT SEED OIL (UNII: 595AO13F11)  
    INGRKALE (UNII: 0Y3L4J38H1)  
    INGRMAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    INGRZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
    INGRPOLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    INGRSODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)  
    INGRTOCOPHEROL (UNII: R0ZB2556P8)  
    INGRCOPPER GLUCONATE (UNII: RV823G6G67)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRASCORBIC ACID (UNII: PQ6CK8PD0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1100 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic03/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/15/2020
    Labeler - Elemis Ltd. (399838895)