FDA.reportPublic FDA data

Lip Balm and Sunstick

Manufacturer
Hit Promotional Products, Inc.
Effective date
2020-07-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:20:54

Label at a glance#

ProductLip Balm and Sunstick
Active ingredientHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure13 sections

Indications and uses

• Helps prevent sunburn • Higher SPF gives more sunburn protection

Dosage and administration

• 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. • 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 sun protection mea...

Label contents#

Full prescribing information#

Active ingredients (Sunscreen)

OTC - ACTIVE INGREDIENT SECTION

(Sunscreen)
Homosalate 10%
Octocrylene 10%
Octisalate 5%
Avobenzone 3%

Active ingredients (Sunscreen Lip Balm)

OTC - ACTIVE INGREDIENT SECTION

(Sunscreen Lip Balm)
Octocrylene 8%
Octyl Salicylate 4%

Purpose (Sunscreen)

OTC - PURPOSE SECTION

Sunscreen

Purpose (Sunscreen Lip Balm)

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection

Warnings

WARNINGS SECTION

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

  • 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.

• 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 sun protection measures including:

  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredients (Sunscreen)

INACTIVE INGREDIENT SECTION

Mineral oil, Ozokerite, Cera Microcristallina, Polyisobutene, Cocos Nucifera Oil, Ethylhexyl Palmitate, Polyethylene, Butyrospermum Parkii Butter, Tridecyl Trimellitate, Fragrance, Tocopheryl Acetate, BHT, Red 40 (CI 16035), Yellow 5 (CI 19140)

Inactive ingredients (Sunscreen Lip Balm)

INACTIVE INGREDIENT SECTION

Mineral oil, Petrolatum, Ozokerite, Polyisobutylene, Butyrospermum Parkii Butter, Bees wax, Cera Microcristallina, Phenoxyethanol, Fragrance, Tocopheryl Acetate, Red 40 (CI 16035), Yellow 5 (CI 19140)

Other information

OTHER SAFETY INFORMATION

• Protect from excessive heat and direct sun.

Principal Display Panel – Sunscreen Lip Balm Stick

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Broad Spectrum SPF 30
Sunscreen – Net Wt. 2g

Broad Spectrum SPF 15
Sunscreen Lip Balm – Net Wt. 4.5g

#9168     Hit®ASI-61125     Made in China
Hit Promotional Products Inc. Largo, FL

image-01
image-01

Label

Principal Display Panel – Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Broad Spectrum SPF 30
Sunscreen – Net Wt. 2g

#9168     Hit®ASI-61125     Made in China
Hit Promotional Products Inc. Largo, FL

image-02
image-02

Label

Principal Display Panel – Lip Balm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Broad Spectrum SPF 15
Sunscreen Lip Balm – Net Wt. 4.5g

#9168     Hit®ASI-61125     Made in China
Hit Promotional Products Inc. Largo, FL

image-03image-03

Label

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70204-71670204-716-01
70204-21570204-215-01
70204-31670204-316-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
MINERAL OILT5L8T28FGPIACT
CERESINQ1LS2UJO3AIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
COCONUT OILQ9L0O73W7LIACT
ETHYLHEXYL PALMITATE2865993309IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
SHEA BUTTERK49155WL9YIACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
CERESINQ1LS2UJO3AIACT
SHEA BUTTERK49155WL9YIACT
YELLOW WAX2ZA36H0S2VIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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
b35d8d02-45d7-46ca-aca3-0c48743712f7b35d8d02-45d7-46ca-aca3-0c48743712f72020-07-17WarningsExact identifier
spl id: b35d8d02-45d7-46ca-aca3-0c48743712f7
spl set id: b35d8d02-45d7-46ca-aca3-0c48743712f7

Reported adverse events (FAERS/openFDA)#

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