FDA.reportPublic FDA data

PRO-COLLAGEN PERFECT DUO

Manufacturer
Elemis Ltd.
Effective date
2023-04-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:26:40

Label at a glance#

ProductPRO-COLLAGEN PERFECT DUO
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE
Label structure10 sections

Indications and uses

helps prevent sunburn higher SPF gives more sunburn protection

Dosage and administration

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...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 1.0%

Octinoxate 1.0%

Octocrylene 0.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • higher SPF gives more sunburn protection

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • on damaged or broken skin

OTC - WHEN USING SECTION

When using this product,

  • keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

US T: 1-855-235-3647

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

The Pro-Collagen Perfect DuoThe Pro-Collagen Perfect Duo

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 71 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65912-01065912-010-01
65912-001

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 84 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RINGR
GLYCERYL STEARATE SEFCZ5MH785IINGR
GLYCERINPDC6A3C0OXINGR
ISONONYL ISONONANOATES4V5BS6GCXINGR
ETHYLHEXYL PALMITATE2865993309INGR
LAURYL LAURATEGPW77G0937INGR
SHEA BUTTERK49155WL9YINGR
ETHYL MACADAMIATEANA2NCS6V1INGR
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATEO4446S9CRAINGR
CETYL ALCOHOL936JST6JCNINGR
PHENOXYETHANOLHIE492ZZ3TINGR
POTASSIUM CETYL PHOSPHATE03KCY6P7UTINGR
JOJOBA OIL724GKU717MINGR
STARCH, RICE4DGK8B7I3SINGR
BUTYLENE GLYCOL3XUS85K0RAINGR
LAMINARIA DIGITATA15E7C67EE8INGR
CHLORPHENESINI670DAL4SZINGR
SESAME OILQX10HYY4QVINGR
WHEAT GERM OIL14C97E680PINGR
AVOCADO OIL6VNO72PFC1INGR
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMINGR
SODIUM DEHYDROACETATE8W46YN971GINGR
OLIVE OIL6UYK2W1W1EINGR
PADINA PAVONICA177U06NHZIINGR
.BETA.-CITRONELLOL, (R)-P01OUT964KINGR
LINALOOL, (+/-)-D81QY6I88EINGR
PHYMATOLITHON CALCAREUM6J1M3WA0ZKINGR
MIMOSA TENUIFLORA BARK515MQE449IINGR
MANNITOL3OWL53L36AINGR
TOCOPHEROLR0ZB2556P8INGR
SORBITAN MONOOLEATE06XEA2VD56INGR
LIMONENE, (+)-GFD7C86Q1WINGR
HYDROXYCITRONELLAL8SQ0VA4YURINGR
MALIC ACID817L1N4CKPINGR
DIATOMACEOUS EARTH2RF6EJ0M85INGR
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0INGR
ASCORBYL PALMITATEQN83US2B0NINGR
ZINC SULFATE, UNSPECIFIED FORM89DS0H96TBINGR
CITRIC ACID MONOHYDRATE2968PHW8QPINGR
SODIUM HYDROXIDE55X04QC32IINGR

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pro-Collagen Marine Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limited3321281e-612b-4305-bf6d-bfab02c65ffb2026-04-03WarningsExact identifier
ndc (product): 65912-001
fa5428f3-1517-d51e-e053-6294a90ad3f8fa543884-7a19-e1f9-e053-6394a90ac0f12023-04-27WarningsExact identifier
spl id: fa5428f3-1517-d51e-e053-6294a90ad3f8
spl set id: fa543884-7a19-e1f9-e053-6394a90ac0f1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.