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

Pro-Collagen Marine by

Drug Labeling and Warnings

Pro-Collagen Marine by is a Otc medication manufactured, distributed, or labeled by ELEMIS Limited. 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 - 50 ml Jar Carton

ANTI-AGEING

ELEMIS

PRO-COLLAGEN
MARINE CREAM SPF 30

Anti-wrinkle day cream
Broad Spectrum SPF 30 | Sunscreen

• 💧 For fine lines and wrinkles
• 💧 Padina Pavonica, Rose, Mimosa
• 💧 Firms, smoothes, hydrates

50 ml e 1.6 US fl.oz.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	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)
4-HYDROXY ACETOPHENONE (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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65912-001-50	1 in 1 CARTON	01/19/2018
1		50 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 65912-001-15	1 in 1 CARTON	01/19/2018
2		15 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 65912-001-51	50 g in 1 JAR; Type 0: Not a Combination Product	01/19/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/19/2018

Labeler - ELEMIS Limited (399838895)