PRO-COLLAGEN TSA TRAVELLER COLLECTION- 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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Pro-Collagen TSA Traveller Collection

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 Carton

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Passport to FIRM & FLAWLESS: Informational Panel.

PRINCIPAL DISPLAY PANEL - Kit Carton

PRO-COLLAGEN TSA TRAVELLER COLLECTION
avobenzone, octinoxate, and octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65912-004

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65912-004-01	1 in 1 BAG	07/01/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 CONTAINER	20 g
Part 2	1 TUBE	15 g
Part 3	1 CONTAINER	15 g
Part 4	1 CONTAINER	2

Part 1 of 4

PRO-COLLAGEN CLEANSING BALM
cleansing (cold creams, cleansing lotions, liquids, and pads) paste

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	ALMOND OIL (UNII: 66YXD4DKO9)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	CAPRYLOCAPROYL POLYOXYLGLYCERIDES 6 (UNII: GO50W2HWO8)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
INGR	PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
INGR	SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
INGR	OAT KERNEL OIL (UNII: 3UVP41R77R)
INGR	WHEAT GERM OIL (UNII: 14C97E680P)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	ORANGE PEEL WAX (UNII: 0U715N387C)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	PADINA PAVONICA (UNII: 177U06NHZI)
INGR	BORAGE SEED OIL (UNII: F8XAG1755S)
INGR	LAVENDER OIL (UNII: ZBP1YXW0H8)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
INGR	COCONUT OIL (UNII: Q9L0O73W7L)
INGR	ROSA MULTIFLORA FLOWER WAX (UNII: VU148CEP2J)
INGR	LAVANDIN OIL (UNII: 9RES347CKG)
INGR	PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
INGR	GERANIOL (UNII: L837108USY)
INGR	EUCALYPTUS OIL (UNII: 2R04ONI662)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
INGR	.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
INGR	JOJOBA OIL (UNII: 724GKU717M)
INGR	ORANGE OIL (UNII: AKN3KSD11B)
INGR	GRAPE SEED OIL (UNII: 930MLC8XGG)
INGR	MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
INGR	CLOVE LEAF OIL (UNII: VCA5491KVF)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		20 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		07/01/2020

Part 2 of 4

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

Product Information
Item Code (Source)	NDC:65912-001
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)
WHEY PROTEIN HYDROLYSATE (UNII: 237DZG2JLA)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65912-001-15	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	07/01/2020

Part 3 of 4

PRO-COLLAGEN OXYGENATING NIGHT
lotions, oils, powders, and creams cream

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
INGR	ETHYLHEXYL PALMITATE (UNII: 2865993309)
INGR	LAURYL LAURATE (UNII: GPW77G0937)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
INGR	PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
INGR	JOJOBA OIL (UNII: 724GKU717M)
INGR	STARCH, RICE (UNII: 4DGK8B7I3S)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	LAMINARIA DIGITATA (UNII: 15E7C67EE8)
INGR	CHLORPHENESIN (UNII: I670DAL4SZ)
INGR	AVOCADO OIL (UNII: 6VNO72PFC1)
INGR	SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	OLIVE OIL (UNII: 6UYK2W1W1E)
INGR	PADINA PAVONICA (UNII: 177U06NHZI)
INGR	ACACIA DECURRENS FLOWER (UNII: 8PHF3LSM61)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
INGR	GERANIOL (UNII: L837108USY)
INGR	MANNITOL (UNII: 3OWL53L36A)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
INGR	MALIC ACID (UNII: 817L1N4CKP)
INGR	DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	ASCORBYL PALMITATE (UNII: QN83US2B0N)
INGR	ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		07/01/2020

Part 4 of 4

PRO-COLLAGEN HYDRA-GEL EYE MASKS
face and neck (excluding shaving preparations) gel

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	LOCUST BEAN GUM (UNII: V4716MY704)
INGR	CARRAGEENAN (UNII: 5C69YCD2YJ)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
INGR	JOJOBA OIL (UNII: 724GKU717M)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	1,2-HEXANEDIOL (UNII: TR046Y3K1G)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	CHLORELLA VULGARIS (UNII: RYQ4R60M02)
INGR	POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
INGR	CASTOR OIL (UNII: D5340Y2I9G)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	PADINA PAVONICA (UNII: 177U06NHZI)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		2 in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		07/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	07/01/2020

Labeler - Elemis Ltd. (399838895)

Registrant - Elemis Ltd. (399838895)

Revised: 12/2022

Document Id: f03a7785-908a-0a2a-e053-2995a90aebca

Set id: 3f015376-a311-471e-b213-b86ba4e92100

Version: 3

Effective Time: 20221219

Elemis Ltd.