FESTIVAL FAVORITES- avobenzone, octinoxate, and octocrylene 
Elemis Ltd.

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.

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Festival Favorites

Drug Facts

Active ingredients

Avobenzone 1.0%
Octinoxate 1.0%
Octocrylene 0.5%

Purpose

Sunscreen

Uses

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

Other information

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
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)  
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
WHEY PROTEIN HYDROLYSATE (UNII: 237DZG2JLA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65912-001-1615 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)

Revised: 12/2021
Document Id: d294d541-3048-6bfe-e053-2995a90a23ea
Set id: a3502d2a-0257-4a8e-bec6-ad565f31b51b
Version: 3
Effective Time: 20211207
 
Elemis Ltd.