FDA.reportPublic FDA data

Soothe and Hydrate Starter Set

Manufacturer
Elemis Ltd.
Effective date
2022-12-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:44:33

Label at a glance#

ProductSoothe and Hydrate Starter Set
Active ingredientOCTOCRYLENE, OCTINOXATE, AVOBENZONE
Label structure9 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.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....

Storage and handling

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

Label contents#

Full prescribing information#

OTC - QUESTIONS SECTION

Questions?
UST: 1-855-235-3647

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

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.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

WARNINGS SECTION

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

INDICATIONS & USAGE SECTION

helps prevent sunburn• higher SPF gives more sunburn protection

Purpose

OTC - PURPOSE SECTION

Sunscreen

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

:
Avobenzone 1.0%
Octionoxate 1.0%
Octocrylene 0.5

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

​ PDPPDP

Products#

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

DailyMed product names page 1 of 3 · 92 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65912-00965912-009-01
65912-00165912-001-16

Ingredients#

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

DailyMed ingredient rows page 1 of 4 · 130 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
EUTERPE OLERACEA WHOLEY57H6218HPINGR
ROSA DAMASCENA FLOWERJWB78P295AINGR
SODIUM HYDROXIDE55X04QC32IINGR
MAGNESIUM ASPARTATER17X820ROLINGR
ZINC GLUCONATEU6WSN5SQ1ZINGR
PADINA PAVONICA177U06NHZIINGR
LACTOBACILLUS FERMENTUM2C1F12C6APINGR
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458INGR
LAURYL GLUCOSIDE76LN7P7UCUINGR
XANTHAN GUMTTV12P4NEEINGR
PHENOXYETHANOLHIE492ZZ3TINGR
CHLORPHENESINI670DAL4SZINGR
SODIUM CHLORIDE451W47IQ8XINGR
SEA SALT87GE52P74GINGR
GLYCERINPDC6A3C0OXINGR
PYRROLIDONE CARBOXYLIC ACID6VT1YZM21HINGR
RHIZOBIAN GUM0XNZ14VU7KINGR
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMINGR
HYALURONATE SODIUMYSE9PPT4THINGR
MIMOSA TENUIFLORA BARK515MQE449IINGR
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AINGR
SUCCINIC ACIDAB6MNQ6J6LINGR
LACTIC ACID33X04XA5ATINGR
WATER059QF0KO0RINGR
SODIUM LAUROYL SARCOSINATE632GS99618INGR
COPPER GLUCONATERV823G6G67INGR
GLYCERINPDC6A3C0OXINGR
SODIUM DEHYDROACETATE8W46YN971GINGR
WATER059QF0KO0RINGR
METHYL GLUCETH-20J3QD0LD11PINGR
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMINGR
CHLORPHENESINI670DAL4SZINGR
TROMETHAMINE023C2WHX2VINGR
SAPONARIA OFFICINALIS LEAF3988313MM7INGR
APRICOT269CJD5GZ9INGR
POLYSORBATE 207T1F30V5YHINGR
POTASSIUM SORBATE1VPU26JZZ4INGR
SODIUM BENZOATEOJ245FE5EUINGR
PHENOXYETHANOLHIE492ZZ3TINGR

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 (package): 65912-001-16
ndc (product): 65912-001
ndc11 (package): 65912000116
efcdfa84-1c2b-b448-e053-2a95a90a2587d296f549-ecfd-57a9-e053-2a95a90a8d8b2022-12-14WarningsExact identifier
spl id: efcdfa84-1c2b-b448-e053-2a95a90a2587
spl set id: d296f549-ecfd-57a9-e053-2a95a90a8d8b

Reported adverse events (FAERS/openFDA)#

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