Label: PRO-COLLAGEN PERFECT DUO- avobenzone, octinoxate, and octocrylene kit
- NDC Code(s): 65912-010-01
- Packager: Elemis Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 27, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
- apply liberally and evenly 15 minutes before sun exposure and as needed
- children under 6 months of age: Ask a doctor
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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
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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?
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
PRO-COLLAGEN PERFECT DUO
avobenzone, octinoxate, and octocrylene kitProduct 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 creamProduct 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 creamProduct 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)
