PRO-COLLAGEN DAY AND NIGHT DUO- 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.

----------

PRO-COLLAGEN DAY & NIGHT DUO

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

PRO-COLLAGEN
DAY & NIGHT DUO

Pro-Collagen Marine Cream SPF 30
Broad Spectrum SPF 30 | Sunscreen
Pro-Collagen Oxygenating Night Cream

ELEMIS

NET WT. 2x 50ml ℮ 1.6 US fl. oz.

Principal Display Panel - Kit Carton
PRO-COLLAGEN DAY AND NIGHT DUO 
avobenzone, octinoxate, and octocrylene kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65912-006
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65912-006-011 in 1 CONTAINER09/01/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 CONTAINER 50 g
Part 21 CONTAINER 50 g
Part 1 of 2
PRO-COLLAGEN OXYGENATING NIGHT 
lotions, oils, powders, and creams cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRPADINA PAVONICA (UNII: 177U06NHZI)  
INGRACACIA DECURRENS FLOWER (UNII: 8PHF3LSM61)  
INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
INGR.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
INGRPHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
INGRGERANIOL (UNII: L837108USY)  
INGRMANNITOL (UNII: 3OWL53L36A)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRSORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
INGRHYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
INGRMALIC ACID (UNII: 817L1N4CKP)  
INGRDIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
INGRZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
INGRETHYLHEXYL PALMITATE (UNII: 2865993309)  
INGRLAURYL LAURATE (UNII: GPW77G0937)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
INGRPROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRPOTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
INGRJOJOBA OIL (UNII: 724GKU717M)  
INGRSTARCH, RICE (UNII: 4DGK8B7I3S)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRLAMINARIA DIGITATA (UNII: 15E7C67EE8)  
INGRCHLORPHENESIN (UNII: I670DAL4SZ)  
INGRSESAME OIL (UNII: QX10HYY4QV)  
INGRWHEAT GERM OIL (UNII: 14C97E680P)  
INGRAVOCADO OIL (UNII: 6VNO72PFC1)  
INGRSODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGROLIVE OIL (UNII: 6UYK2W1W1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
150 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic09/01/2019
Part 2 of 2
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)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
150 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/01/2019
Labeler - Elemis Ltd. (399838895)

Revised: 12/2022
 
Elemis Ltd.