Fresh Sugar Lip Treatment SPF 15

Manufacturer
Fresh Inc.
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:17:07

Label at a glance#

ProductFresh Sugar Lip Treatment SPF 15
Active ingredientOCTINOXATE, OXYBENZONE
Label structure8 sections

Dosage and administration

For sunscreen use: ▀ Apply liberally 15 minutes before sun exposure ▀ Use a water resistant sunscreen if swimming or sweating ▀ Reapply at least every 2 hours ▀ Children under 6 months: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.49%
Oxybenzone 2.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert; Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:
▀ Apply liberally 15 minutes before sun exposure
▀ Use a water resistant sunscreen if swimming or sweating
▀ Reapply at least every 2 hours
▀ Children under 6 months: Ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

Protect this product in container from excessive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1(800)FRESH-20 Monday-Friday (9 a.m. to 5p.m EST)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cera Alba (Beeswax), Ricinus Communis (Castor) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrogenated Olive Oil Decyl Esters, Vitis Vinifera (Grape) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Sucrose Tetrastearate Triacetate, Triticum Vulgare (Wheat) Germ Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Persea Gratissima (Avocado) Oil, Ribes Nigrum (Black Currant) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Prunus Armeniaca (Apricot) Kernel Oil, Retinyl Palmitate, Ascorbyl Tetraisopalmitate, Ascorbyl Palmitate, Parfum (Fragrance), BHT, Tocopherol, Limonene, Citral, Benzyl Benzoate, Linalool, Benzyl Alcohol, Geraniol, Citronellol<05039/A>

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

InnerInnerDrugFactsDrugFactsBoxBox

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
OXYBENZONEACTIVE MOIETY95OOS7VE0Y2
.BETA.-CITRONELLOL, (R)-INACTIVE INGREDIENTP01OUT964K2
APRICOT KERNEL OILINACTIVE INGREDIENT54JB35T06A2
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0N2
ASCORBYL TETRAISOPALMITATEINACTIVE INGREDIENT47143LT58A2
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC12
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH2
BENZYL BENZOATEINACTIVE INGREDIENTN863NB338G2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ2
CASTOR OILINACTIVE INGREDIENTD5340Y2I9G2
CITRALINACTIVE INGREDIENTT7EU0O9VPP2
GERANIOLINACTIVE INGREDIENTL837108USY2
GRAPE SEED OILINACTIVE INGREDIENT930MLC8XGG2
HYDROGENATED OLIVE OIL DECYL ESTERSINACTIVE INGREDIENTXQ691JJ99N2
JOJOBA OILINACTIVE INGREDIENT724GKU717M2
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88E2
MEADOWFOAM SEED OILINACTIVE INGREDIENT412ZHA4T4Y2
RIBES NIGRUM SEED OILINACTIVE INGREDIENTGKE11888372
SUCROSE TETRASTEARATE TRIACETATEINACTIVE INGREDIENT1K7LBQ045N2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI2
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P82
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC2
WHEAT GERM OILINACTIVE INGREDIENT14C97E680P2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V2

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
42406-01642406-016-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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 3 · 133 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY / TOPICAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE, EXTENDED RELEASE / ORAL1.23 mgExact identifier — unii candidate
50 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / TOPICAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
50 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS0.02 mgExact identifier — unii candidate
32 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCONJUNCTIVAL252 mgExact identifier — unii candidate
50 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NSOLUTION / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / VAGINAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZCAPSULE / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, EXTENDED RELEASE / ORAL2150 mgExact identifier — unii candidate
11 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET / ORAL17 mgExact identifier — unii candidate
16 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAVENOUS1620 mgExact identifier — unii candidate
50 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAVENOUS242 mgExact identifier — unii candidate
50 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZGUM, CHEWING / BUCCAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRAMUSCULAR500 mgExact identifier — unii candidate
50 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / ORAL14 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / VAGINALNAExact identifier — unii candidate
32 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET / ORAL1.06 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRA-ARTICULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / SUBCUTANEOUS225 mgExact identifier — unii candidate
50 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GCAPSULE, EXTENDED RELEASE / ORAL47 mgExact identifier — unii candidate
16 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GOINTMENT / TOPICAL14.9 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GINJECTION / INTRAMUSCULAR885 mgExact identifier — unii candidate
16 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / VAGINAL0.05 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NCAPSULE / ORAL12 mgExact identifier — unii candidate
6 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
50 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / SUBCUTANEOUS0.95 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAMUSCULAR225 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL BENZOATEBENZYL BENZOATEN863NB338GINJECTION, SOLUTION / INTRAMUSCULAR750 mgExact identifier — unii candidate
4 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / RECTAL129 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 ALCOHOLLKG8494WBHSUSPENSION / ORAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GGRANULE, FOR SUSPENSION / ORAL128 mgExact identifier — unii candidate
16 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, COATED / ORAL207.5 mgExact identifier — unii candidate
11 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM, AUGMENTED / TOPICAL0.2 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KFILM, SOLUBLE / ORAL0.06 mgExact identifier — unii candidate
32 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSPRAY / NASALNAExact identifier — unii candidate
16 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTERIAL0.9 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii candidate
50 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED, EXTENDED RELEASE / ORAL140 mgExact identifier — unii candidate
11 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSOLUTION / TOPICAL1.38 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRALESIONAL20 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR144 mgExact identifier — unii candidate
50 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRACAVITARY0.01 mlExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRALESIONAL23 mgExact identifier — unii candidate
50 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GEMULSION / OPHTHALMIC32 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, FILM COATED / ORAL15.29 mgExact identifier — unii candidate
16 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCUTANEOUS90 mgExact identifier — unii candidate
50 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
ef67dc5e-1d5d-d77c-e053-2a95a90a2a11696cce52-ff59-417f-8c88-17cee8d5b3492022-12-09WarningsExact identifier
spl set id: 696cce52-ff59-417f-8c88-17cee8d5b349

Reported adverse events (FAERS/openFDA)#

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