Sea Pure Hydrating

Manufacturer
H2O PLUS
Effective date
2011-09-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:37

Label at a glance#

ProductSea Pure Hydrating Sea Pure Hydrating SPF20
Active ingredientTitanium Dioxide
Label structure2 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


Titanium Dioxide4.0%

OTC - WHEN USING SECTION


Helps prevent sunburns
If used as directed with other sun protection measure ( see directions)decreases the risk of skin
cancers/ and early skin aging

WARNINGS SECTION


For external use only
Do not use on damaged or broken skin
Stop use and ask a doctor is a rash occurs
When using this product* keep out of eyes, Rinse with water to remove.
Keep out of reach of children. If swallowed, get medical help or contact a Poison control center right
away

DOSAGE & ADMINISTRATION SECTION


For Sunscreen Use
Apply Liberally
Children under six months of age: Ask a doctor

STORAGE AND HANDLING SECTION

Protect this product in this container from excessive heat and direct sunlight

INACTIVE INGREDIENT SECTION

Enter section text here

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton label sphl295.jpgimage of carton labelimage of carton label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65903-295-012019-11-13C16284748780-197449f38-c5ae-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65903-295-01Sea Pure HydratingSea Pure Hydrating SPF201 in 1 CARTONLOTION11
65903-295-01Sea Pure HydratingSea Pure Hydrating SPF2050 mL in 1 BOTTLE, PUMPLOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65903-295SEA PURE HYDRATING SEA PURE HYDRATING SPF20 (TITANIUM DIOXIDE) LOTION [H2O PLUS]1Legacy NDC, 2 package rows20120119_733912b9-1d07-4d85-9750-7ce29351f8d4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
Titanium DioxideACTIVE MOIETY15FIX9V2JP1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
CAESALPINIA SPINOSA RESININACTIVE INGREDIENTWL3883U2PO1
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNA1
CETEARYL OLIVATEINACTIVE INGREDIENT58B69Q84JO1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CITRUS MAXIMA FRUIT RIND OILINACTIVE INGREDIENT8U3877WD441
CITRUS SINENSIS FLOWER OILINACTIVE INGREDIENTAJ56JP5TFP1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7L1
CORN OILINACTIVE INGREDIENT8470G57WFM1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
JOJOBA OILINACTIVE INGREDIENT724GKU717M1
JUNIPERUS DEPPEANA WOOD OILINACTIVE INGREDIENT4739QA56861
LEMON OILINACTIVE INGREDIENTI9GRO824LL1
LIME OILINACTIVE INGREDIENTUZH29XGA8G1
LIMONENE, (-)-INACTIVE INGREDIENT47MAJ1Y2NE1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
PELARGONIUM GRAVEOLENS FLOWER OILINACTIVE INGREDIENT3K0J1S7QGC1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S71
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4T1
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM3931
SORBITAN OLIVATEINACTIVE INGREDIENTMDL271E3GR1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
ULVA COMPRESSAINACTIVE INGREDIENTSXZ209FM331
waterINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65903-29565903-295-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 229 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY, METERED / SUBLINGUAL110 mgExact identifier — unii candidate
18 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SSPRAY / TOPICAL1 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLSUSPENSION / ORAL1 mgExact identifier — unii candidate
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii candidate
29 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRASYNOVIAL18 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii candidate
18 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / VAGINAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SLOTION / TOPICAL3627 mgExact identifier — unii candidate
9 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / OPHTHALMIC2 mgExact identifier — unii candidate
29 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLIQUID / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS144 mgExact identifier — unii candidate
50 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLPASTE, DENTIFRICE / DENTAL0.7 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAVENOUS242 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY8.4 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAVENOUS45 mgExact identifier — unii candidate
50 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS990.3 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / RECTAL452 mgExact identifier — unii candidate
29 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMSUSPENSION, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SOFT TISSUE23 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
13 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / RECTAL129 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TPASTILLE / ORALADJ PHExact identifier — unii candidate
13 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / VAGINAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
CITRUS SINENSIS FLOWER OILCITRUS SINENSIS FLOWER OILAJ56JP5TFPTABLET / ORALNAExact identifier — unii candidate
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii candidate
18 equally ranked IID candidates

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
c482c8a4-3e32-4950-969c-cc09a455ac2b733912b9-1d07-4d85-9750-7ce29351f8d42011-09-29WarningsExact identifier
spl id: c482c8a4-3e32-4950-969c-cc09a455ac2b
spl set id: 733912b9-1d07-4d85-9750-7ce29351f8d4

Reported adverse events (FAERS/openFDA)#

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