ULTIMATE PRO-COLLAGEN DAY AND NIGHT DUO- avobenzone, octinoxate, and octocrylene kit

ULTIMATE PRO-COLLAGEN DAY AND NIGHT DUO by

Drug Labeling and Warnings

ULTIMATE PRO-COLLAGEN DAY AND NIGHT DUO by is a Otc medication manufactured, distributed, or labeled by Elemis Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Container

ULTIMATE PRO-COLLAGEN
DAY & NIGHT DUO

Pro-Collagen Marine Cream SPF 30
Broad Spectrum SPF 30 | Sunscreen
Pro-Collagen Overnight Matrix

NET WT. 2x 50ml e 1.6 US fl. oz.

ELEMIS

INGREDIENTS AND APPEARANCE

ULTIMATE PRO-COLLAGEN DAY AND NIGHT DUO 
avobenzone, octinoxate, and octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65912-008

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65912-008-01	1 in 1 CONTAINER	09/01/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 CONTAINER	50 g
Part 2	1 CONTAINER	50 g

Part 1 of 2

PRO-COLLAGEN OVERNIGHT MATRIX 
lotions, oils, powders, and creams soap

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	CORN OIL (UNII: 8470G57WFM)
INGR	Propanediol (UNII: 5965N8W85T)
INGR	DOCOSANOL (UNII: 9G1OE216XY)
INGR	Squalane (UNII: GW89575KF9)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	OCTYLDODECANOL (UNII: 461N1O614Y)
INGR	Dicaprylyl Carbonate (UNII: 609A3V1SUA)
INGR	SUNFLOWER OIL (UNII: 3W1JG795YI)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
INGR	Beheneth-25 (UNII: 0G17KJ5M7P)
INGR	Benzoic Acid (UNII: 8SKN0B0MIM)
INGR	LAVENDER OIL (UNII: ZBP1YXW0H8)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	DUNALIELLA SALINA (UNII: F4O1DKI9A6)
INGR	Rhizobian Gum (UNII: 0XNZ14VU7K)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	Dehydroacetic Acid (UNII: 2KAG279R6R)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	LAVANDIN OIL (UNII: 9RES347CKG)
INGR	Pelargonium Graveolens Flower Oil (UNII: 3K0J1S7QGC)
INGR	PADINA PAVONICA (UNII: 177U06NHZI)
INGR	Geraniol (UNII: L837108USY)
INGR	EUCALYPTUS OIL (UNII: 2R04ONI662)
INGR	Chlorphenesin (UNII: I670DAL4SZ)
INGR	CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
INGR	.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
INGR	Potassium Sorbate (UNII: 1VPU26JZZ4)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Caramel (UNII: T9D99G2B1R)
INGR	CAMPHOR LEAF OIL (UNII: 51D0RGY52V)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
INGR	Tocopherol (UNII: R0ZB2556P8)
INGR	Xanthan Gum (UNII: TTV12P4NEE)
INGR	Caprylyl Glycol (UNII: 00YIU5438U)
INGR	ORANGE OIL (UNII: AKN3KSD11B)
INGR	TEPHROSIA PURPUREA SEED (UNII: 01KT5NC1TC)
INGR	GRAPE SEED OIL (UNII: 930MLC8XGG)
INGR	MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
INGR	CLOVE LEAF OIL (UNII: VCA5491KVF)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
INGR	Phenylpropanol (UNII: 0F897O3O4M)
INGR	POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		50 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		09/01/2019

Part 2 of 2

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

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		50 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/01/2019

Labeler - Elemis Ltd. (399838895)