Soothe & Hydrate Starter Set

Soothe and Hydrate Starter Set by

Drug Labeling and Warnings

Soothe and Hydrate Starter Set by is a Otc medication manufactured, distributed, or labeled by Elemis Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SOOTHE AND HYDRATE STARTER SET- 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.

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Soothe & Hydrate Starter Set

Questions?
UST: 1-855-235-3647

Inactive Ingredients

Water, Glycerine. Caprylic/Capric Triglyceride, Glyceryl StearateS E. lsononyl
lsononanoate. Dicaprylyt Carbonate, Dimethicone, Phenoxythanol,
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, Chiarella Vulgaris Extract, Glyceryl Polyacrylate, Glyceryl
Acrylate/Acrylic Acid Copolymer, Padina Pavonica Thallus Extract, Sodium
Dehydroacetate, Polysorbate 20, Sorbitan lsostearate, Ginkgo Biloba Leaf
Extract. Porphyridium Cruentum Extract. Acacia Decurrens (Mimosa) Flower
Extract. Rosa Centifola (Rose) Flower Extract. Sodium Benzoate. Potassium
Sorbate, Citric Acid.

Other information

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

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.S pending 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 SpectrumS PF value of 15 or higher and other sun protection measures
including· limit time in the sun, especially from 1 0a.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

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 oU1 of reach of children. If swallowed, get medical help or contact
a Poison Control Center right away.

Uses

helps prevent sunburn higher SPF gives more sunburn protection

Purpose

Sunscreen

Active Ingredients

:
Avobenzone 1.0%
Octionoxate 1.0%
Octocrylene 0.5

ELEMIS

LONDON

Soothe & Hydrate
Starter Set
SKIN SOOTHING & DEEPLY HYDRATING FAVOURITES
Pro-Collagen Energising Marine Cleanser 150ml e 5.0 US fl.oz. I Soothing Apricot Toner 50ml e 1.6 US fl.oz.
Pro-Collagen Marine Moisture Essence 28ml e 0.9 US fl.oz. I Pro-Collagen Hydra-Gel Eye Masks 1 x Pair
Pro-CollagenMarine Cream SPF 30 15ml e 0.5 US. fl.oz.

PDP

SOOTHE AND HYDRATE STARTER SET 
avobenzone, octinoxate, and octocrylene kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65912-009
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65912-009-011 in 1 CONTAINER10/01/2021
11 in 1 BOX
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1 150 
Part 2 50 
Part 3 28 
Part 41 CONTAINER
Part 51 TUBE 15 g
Part 1 of 5
PRO-COLLAGEN ENERGISING MARINE CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) soap
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGREUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)  
INGRROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRMAGNESIUM ASPARTATE (UNII: R17X820ROL)  
INGRZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
INGRPADINA PAVONICA (UNII: 177U06NHZI)  
INGRLACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
INGRLEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
INGRLAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRCHLORPHENESIN (UNII: I670DAL4SZ)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRSEA SALT (UNII: 87GE52P74G)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPYRROLIDONE CARBOXYLIC ACID (UNII: 6VT1YZM21H)  
INGRRHIZOBIAN GUM (UNII: 0XNZ14VU7K)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRMIMOSA TENUIFLORA BARK (UNII: 515MQE449I)  
INGRGUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
INGRSUCCINIC ACID (UNII: AB6MNQ6J6L)  
INGRLACTIC ACID (UNII: 33X04XA5AT)  
INGRWATER (UNII: 059QF0KO0R)  
INGRSODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
INGRCOPPER GLUCONATE (UNII: RV823G6G67)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic10/01/2021
Part 2 of 5
SOOTHING APRICOT TONER 
other skin care preparations liquid
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRSODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
INGRWATER (UNII: 059QF0KO0R)  
INGRMETHYL GLUCETH-20 (UNII: J3QD0LD11P)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRCHLORPHENESIN (UNII: I670DAL4SZ)  
INGRTROMETHAMINE (UNII: 023C2WHX2V)  
INGRSAPONARIA OFFICINALIS LEAF (UNII: 3988313MM7)  
INGRAPRICOT (UNII: 269CJD5GZ9)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRQUILLAJA SAPONARIA SAPONINS FRACTION A (UNII: HTP8T7ATZ9)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic10/01/2021
Part 3 of 5
PRO-COLLAGEN MARINE MOISTURE ESSENCE 
moisturizing liquid
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRSORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
INGRPEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRAMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
INGRWATER (UNII: 059QF0KO0R)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRSODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRTERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
INGRMAGNESIUM ASPARTATE (UNII: R17X820ROL)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRPADINA PAVONICA (UNII: 177U06NHZI)  
INGRROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)  
INGRZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRLEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRCHLORELLA VULGARIS (UNII: RYQ4R60M02)  
INGRTRIDECETH-9 (UNII: X9HD79I514)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRLACTOBIONIC ACID (UNII: 65R938S4DV)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
INGRMIMOSA TENUIFLORA BARK (UNII: 515MQE449I)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
INGRCOPPER GLUCONATE (UNII: RV823G6G67)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic11/01/2021
Part 4 of 5
PRO-COLLAGEN HYDRA-GEL EYE MASKS 
face and neck (excluding shaving preparations) gel
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRCHLORELLA VULGARIS (UNII: RYQ4R60M02)  
INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
INGRCITRUS JUNOS FRUIT (UNII: 53KHW58C1V)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPADINA PAVONICA (UNII: 177U06NHZI)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRCASTOR OIL (UNII: D5340Y2I9G)  
INGRJOJOBA OIL (UNII: 724GKU717M)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRLOCUST BEAN GUM (UNII: V4716MY704)  
INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
INGRCARRAGEENAN (UNII: 5C69YCD2YJ)  
INGRPOTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
INGRSCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
INGRARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
INGRPEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
INGRWATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 CONTAINER; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic10/01/2021
Part 5 of 5
PRO-COLLAGEN MARINE  BROAD SPECTRUM SPF 30
avobenzone, octinoxate, and octocrylene cream
Product Information
Item Code (Source)NDC: 65912-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE10 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
GINKGO (UNII: 19FUJ2C58T)  
ACACIA DECURRENS FLOWER (UNII: 8PHF3LSM61)  
PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
PADINA PAVONICA (UNII: 177U06NHZI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
SHEA BUTTER (UNII: K49155WL9Y)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CARROT (UNII: L56Z1JK48B)  
WHEAT GERM OIL (UNII: 14C97E680P)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65912-001-1615 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/01/2021
Labeler - Elemis Ltd. (399838895)

Revised: 12/2022
 

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