FDA.reportPublic FDA data

Hydrator Plus

Manufacturer
CP Skin Health Group, Inc.
Effective date
2024-02-14
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:08:39

Label at a glance#

ProductHydrator Plus SPF 30
Active ingredientOCTOCRYLENE, OCTISALATE, ZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every two hours Children under 6 months: as a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other skin protecting measures incl...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octisalate (4.9%)

Octocrylene (9.5%)

Zinc Oxide (5.4%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only.

Do not use on damaged or broken skin

Stop use and ask a doctor if skin rash occurs

When using this product keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every two hours

Children under 6 months: as a doctor.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other skin protecting measures including: limit time in the sun, especially from 10 a.m. - 2 p.m., wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Avena Sativa (Oat) Bran Extract

Betaine

Bisabolol

Butyloctyl Salicylate

Caffeine

Ceteareth-20

Cetearyl Olivate

Citrus Aurantium Dulcis (Orange) Peel Extract

Coco-Caprylate/Caprate

Coconut Alkanes

Cyclopentasiloxane

Dimethicone

Ethylhexylgylcerin

Glycerin

Hydrolyzed Jojoba Esters

Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer

Octyldodecyl Neopentanoate

PEG-7 Trimethylolpropane Coconut Ether

Phenoxyethanol

Polyisobutene

Propanediol

Sodium Hyaluronate

Sodium PCA

Sorbitan Olivate

Tetradecane

Tocopheryl Acetate

Tremella Fuciformis Sporocarp Extract

Triethoxycaprylylsilane

Water

Questions

OTC - QUESTIONS SECTION

Please call 877-722-7546

Hydrator Plus

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrator PlusHydrator Plus

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68726-263-11Hydrator PlusSPF 3050 mL in 1 TUBELOTION506
68726-263-37Hydrator PlusSPF 307.4 mL in 1 TUBELOTION7.46
68726-263-53Hydrator PlusSPF 30195 mL in 1 BOTTLELOTION1956

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68726-263HYDRATOR PLUS SPF 30 (BROAD SPECTRUM) LOTION [CP SKIN HEALTH GROUP, INC.]6Current NDC, Legacy NDC, 3 package rows20240215_b6c0db82-9fba-6216-e053-2a95a90a7560.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68726-26368726-263-11, 68726-263-37, 68726-263-53

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
ORANGE PEELTI9T76XD44IACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
HYALURONATE SODIUMYSE9PPT4THIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
LEVOMENOL24WE03BX2TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
OAT BRANKQX236OK4UIACT
SORBITAN OLIVATEMDL271E3GRIACT
COCONUT ALKANES1E5KJY107TIACT
ZINC OXIDESOI2LOH54ZACTIB
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CYCLOMETHICONE 50THT5PCI0RIACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
CAFFEINE3G6A5W338EIACT
TETRADECANE03LY784Y58IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
DIMETHICONE92RU3N3Y1OIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
TREMELLA FUCIFORMIS FRUITING BODYGG8N28393GIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPANEDIOL5965N8W85TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CETEARYL OLIVATE58B69Q84JOIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BETAINE3SCV180C9WIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrator Plus SPF 30BROAD SPECTRUMCP Skin Health Group, Inc.b6c0db82-9fba-6216-e053-2a95a90a75602024-02-14WarningsExact identifier
ndc (package): 68726-263-53
ndc (package): 68726-263-37
ndc (package): 68726-263-11
ndc (product): 68726-263
ndc11 (package): 68726026337
ndc11 (package): 68726026353
ndc11 (package): 68726026311
spl id: 115b3f22-1540-f1ae-e063-6394a90abaee
spl set id: b6c0db82-9fba-6216-e053-2a95a90a7560

Reported adverse events (FAERS/openFDA)#

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