FDA.reportPublic FDA data

SUGAR LIP TREATMENT SUNSCREEN SPF 15

Manufacturer
Fresh Inc
Effective date
2021-12-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:22:20

Label at a glance#

ProductSUGAR LIP TREATMENT SUNSCREEN SPF 15
Active ingredientAVOBENZONE, OCTINOXATE
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

Avobenzone 2.00%
Octinoxate 7.49%

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

Ricinus Communis (Castor) Seed Oil, Cera Alba (Beeswax), Hydrogenated Olive Oil Decyl Esters, Simmondsia Chinensis (Jojoba) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Parfum (Fragrance), Copernicia Cerifera (Carnauba) Wax, Persea Gratissima (Avocado) Oil, Limnanthes Alba  (Meadowfoam) Seed Oil, Passiflora Incarnata Seed Oil, Sucrose Tetrastearate Triacetate, Citrus Limon (Lemon) Peel Oil, Ribes Nigrum (Black Currant) Seed Oil, Tocopherol, Ascorbyl Tetraisopalmitate, Ascorbyl Palmitate, Ammonium Glycyrrhizate, Vanillin, BHT, Limonene, Citral, Benzyl Alcohol, Linalool, Geraniol <10705/Z>

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42406-03242406-032-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
CASTOR OILD5340Y2I9GIACT
YELLOW WAX2ZA36H0S2VIACT
HYDROGENATED OLIVE OIL DECYL ESTERSXQ691JJ99NIACT
GRAPE SEED OIL930MLC8XGGIACT
CARNAUBA WAXR12CBM0EIZIACT
AVOCADO OIL6VNO72PFC1IACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
PASSIFLORA INCARNATA SEED OILS0SU5AC95JIACT
SUCROSE TETRASTEARATE TRIACETATE1K7LBQ045NIACT
LEMON OILI9GRO824LLIACT
RIBES NIGRUM SEED OILGKE1188837IACT
TOCOPHEROLR0ZB2556P8IACT
ASCORBYL TETRAISOPALMITATE47143LT58AIACT
ASCORBYL PALMITATEQN83US2B0NIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
VANILLINCHI530446XIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
LIMONENE, (+)-GFD7C86Q1WIACT
CITRALT7EU0O9VPPIACT
BENZYL ALCOHOLLKG8494WBHIACT
LINALOOL, (+/-)-D81QY6I88EIACT
GERANIOLL837108USYIACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB

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
d364c21b-b064-2f1e-e053-2995a90a398de51c83cd-249f-49da-a7f8-16b9bec26c2c2021-12-17WarningsExact identifier
spl id: d364c21b-b064-2f1e-e053-2995a90a398d
spl set id: e51c83cd-249f-49da-a7f8-16b9bec26c2c

Reported adverse events (FAERS/openFDA)#

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