Label: GIFT OF PRO-COLLAGEN ICONS- avobenzone, octinoxate, and octocrylene kit
- NDC Code(s): 65912-011-01
- 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 June 6, 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
GIFT OF PRO-COLLAGEN ICONS
avobenzone, octinoxate, and octocrylene kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65912-011 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65912-011-01 1 in 1 BOX 09/01/2023 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CONTAINER 50 g Part 2 1 CONTAINER 50 g Part 1 of 2 PRO-COLLAGEN CLEANSING BALM
cleansing (cold creams, cleansing lotions, liquids, and pads) pasteProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR ALMOND OIL (UNII: 66YXD4DKO9) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR CAPRYLOCAPROYL POLYOXYLGLYCERIDES 6 (UNII: GO50W2HWO8) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) INGR PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F) INGR SILICON DIOXIDE (UNII: ETJ7Z6XBU4) INGR OAT KERNEL OIL (UNII: 3UVP41R77R) INGR WHEAT GERM OIL (UNII: 14C97E680P) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR ORANGE PEEL WAX (UNII: 0U715N387C) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR PADINA PAVONICA (UNII: 177U06NHZI) INGR BORAGE SEED OIL (UNII: F8XAG1755S) INGR LAVENDER OIL (UNII: ZBP1YXW0H8) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) INGR COCONUT OIL (UNII: Q9L0O73W7L) INGR ROSA MULTIFLORA FLOWER WAX (UNII: VU148CEP2J) INGR LAVANDIN OIL (UNII: 9RES347CKG) INGR PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) INGR GERANIOL (UNII: L837108USY) INGR EUCALYPTUS OIL (UNII: 2R04ONI662) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) INGR JOJOBA OIL (UNII: 724GKU717M) INGR ORANGE OIL (UNII: AKN3KSD11B) INGR GRAPE SEED OIL (UNII: 930MLC8XGG) INGR MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) INGR CLOVE LEAF OIL (UNII: VCA5491KVF) INGR CITRAL (UNII: T7EU0O9VPP) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR PEG-8 BEESWAX (UNII: 3C1QUF1TIR) INGR SAMBUCUS NIGRA FLOWER OIL (UNII: Q35633V53D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 50 g in 1 CONTAINER; Type 0: Not a Combination Product 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) POLYACRYLATE-13 (UNII: FS2D4T67EA) GLYCERYL ACRYLATE/ACRYLIC ACID COPOLYMER (300000 CP AT 2%) (UNII: MEA9KH24QG) 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) Registrant - Elemis Ltd. (399838895)
