PRO-COLLAGEN PERFECT DUO- avobenzone, octinoxate, and octocrylene kit

PRO-COLLAGEN PERFECT DUO by

Drug Labeling and Warnings

PRO-COLLAGEN PERFECT 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 Carton

The Pro-Collagen Perfect Duo

Pro-Collagen Marine Cream SPF 30

Broad Spectrum SPF 30 | Sunscreen

Pro-Collagen Night Cream

ELEMIS

NET WT. 2x 50ml ℮ 1.6 US fl. oz.

INGREDIENTS AND APPEARANCE

PRO-COLLAGEN PERFECT DUO 
avobenzone, octinoxate, and octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65912-010

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65912-010-01	1 in 1 BOX	09/01/2023

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

Part 1 of 2

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

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
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	SESAME OIL (UNII: QX10HYY4QV)
INGR	WHEAT GERM OIL (UNII: 14C97E680P)
INGR	AVOCADO OIL (UNII: 6VNO72PFC1)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
INGR	OLIVE OIL (UNII: 6UYK2W1W1E)
INGR	PADINA PAVONICA (UNII: 177U06NHZI)
INGR	.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)
INGR	MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)
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)
INGR	HEXAPEPTIDE-9 (UNII: L25414IE41)
INGR	GERANIOL (UNII: L837108USY)
INGR	LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
INGR	GLYCERYL ACRYLATE/ACRYLIC ACID COPOLYMER (300000 CP AT 2%) (UNII: MEA9KH24QG)

Product Characteristics
color	white	C48325

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		50 mL 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		09/01/2023

Part 2 of 2

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

Product Information
Item Code (Source)	NDC: 65912-001
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)
GLYCERYL ACRYLATE/ACRYLIC ACID COPOLYMER (300000 CP AT 2%) (UNII: MEA9KH24QG)
POLYACRYLATE-13 (UNII: FS2D4T67EA)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

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	09/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/01/2023

Labeler - Elemis Ltd. (399838895)