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

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

FESTIVAL FAVORITES
avobenzone, octinoxate, and octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65912-005

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65912-005-01	1 in 1 BAG	03/15/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	30 g
Part 2	1 TUBE	15 g
Part 3	1 BOTTLE, SPRAY	100 g

Part 1 of 3

SUPERFOOD FACIAL WASH
cleansing (cold creams, cleansing lotions, liquids, and pads) soap

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	METHYL GLUCETH-20 (UNII: J3QD0LD11P)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	CHLORPHENESIN (UNII: I670DAL4SZ)
INGR	COCONUT WATER (UNII: 267F5Y81NT)
INGR	.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
INGR	SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	ORANGE OIL (UNII: AKN3KSD11B)
INGR	AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)
INGR	PALMAROSA OIL (UNII: 0J3G3O53ST)
INGR	GERANIOL (UNII: L837108USY)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	ROSEMARY OIL (UNII: 8LGU7VM393)
INGR	ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	CARROT SEED OIL (UNII: 595AO13F11)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
INGR	1,2-HEXANEDIOL (UNII: TR046Y3K1G)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		03/15/2019

Part 2 of 3

PRO-COLLAGEN MARINE SPF 30
avobenzone, octinoxate, and octocrylene cream

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	10 mg in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	10 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65912-001-16	15 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	03/15/2019

Part 3 of 3

SUPERFOOD KEFIR-TEA MIST
skin fresheners spray

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	SODIUM LACTATE (UNII: TU7HW0W0QT)
INGR	COCO GLUCOSIDE (UNII: ICS790225B)
INGR	GLYCERYL OLEATE (UNII: 4PC054V79P)
INGR	DICAPRYLYL ETHER (UNII: 77JZM5516Z)
INGR	LAURYL ALCOHOL (UNII: 178A96NLP2)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	AVOCADO OIL (UNII: 6VNO72PFC1)
INGR	CHLORPHENESIN (UNII: I670DAL4SZ)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
INGR	BROCCOLI SEED OIL (UNII: SY01LVD4G4)
INGR	PUMPKIN SEED OIL (UNII: 6E5QR5USSP)
INGR	GALACTOARABINAN (UNII: SL4SX1O487)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	CHIA SEED OIL (UNII: MC2LH51BO7)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	ORANGE OIL (UNII: AKN3KSD11B)
INGR	SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
INGR	CARAMEL (UNII: T9D99G2B1R)
INGR	AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)
INGR	PALMAROSA OIL (UNII: 0J3G3O53ST)
INGR	GERANIOL (UNII: L837108USY)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	ROSEMARY OIL (UNII: 8LGU7VM393)
INGR	CARROT SEED OIL (UNII: 595AO13F11)
INGR	KALE (UNII: 0Y3L4J38H1)
INGR	MAGNESIUM ASPARTATE (UNII: R17X820ROL)
INGR	ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
INGR	SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	COPPER GLUCONATE (UNII: RV823G6G67)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	ASCORBIC ACID (UNII: PQ6CK8PD0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		100 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		03/15/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	03/15/2020

Labeler - Elemis Ltd. (399838895)

Revised: 12/2022

Document Id: f039e974-50a7-033f-e053-2995a90a682a

Set id: a3502d2a-0257-4a8e-bec6-ad565f31b51b

Version: 4

Effective Time: 20221219

Elemis Ltd.