Lip Balm and Sunstick by Hit Promotional Products, Inc. Lip Balm and Sunstick

Lip Balm and Sunstick by

Drug Labeling and Warnings

Lip Balm and Sunstick by is a Otc medication manufactured, distributed, or labeled by Hit Promotional Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LIP BALM AND SUNSTICK- homosalate, octocrylene, octisalate, avobenzone 
Hit Promotional Products, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Lip Balm and Sunstick

Active ingredients (Sunscreen)

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

Active ingredients (Sunscreen Lip Balm)

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

Purpose (Sunscreen)

Sunscreen

Purpose (Sunscreen Lip Balm)

Sunscreen

Uses

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection

Warnings

For external use only.

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

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

Directions

  • 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)

Mineral oil, Ozokerite, Cera Microcristallina, Polyisobutene, Cocos Nucifera Oil, Ethylhexyl Palmitate, Polyethylene, Butyrospermum Parkii Butter, Tridecyl Trimellitate, Fragrance, Tocopheryl Acetate, BHT, Blue 1 Lake (CI 42090)

Inactive ingredients (Sunscreen Lip Balm)

Mineral oil, Petrolatum, Ozokerite, Polyisobutylene, Butyrospermum Parkii Butter, Bees wax, Cera Microcristallina, Phenoxyethanol, Fragrance, Tocopheryl Acetate, Blue 1 Lake (CI 42090)

Other information

Protect from excessive heat and direct sun.

Principal Display Panel – Lip Balm and Sunstick

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

Label

Principal Display Panel – Sunscreen

Broad Spectrum SPF 30
Sunscreen – Net Wt. 2g

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

image-02

Label

Principal Display Panel – Lip Balm

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-03

Label

LIP BALM AND SUNSTICK 
homosalate, octocrylene, octisalate, avobenzone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70204-715
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70204-715-011 in 1 CARTON; Type 0: Not a Combination Product04/30/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 2 g
Part 21 TUBE 4.5 g
Part 1 of 2
BROAD SPECTRUM SPF 30 SUNSCREEN 
homosalate, octocrylene, octisalate, avobenzone stick
Product Information
Item Code (Source)NDC: 70204-214
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
CERESIN (UNII: Q1LS2UJO3A)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70204-214-012 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/30/2020
Part 2 of 2
BROAD SPECTRUM SPF 15 LIP BALM 
octocrylene, octyl salicylate stick
Product Information
Item Code (Source)NDC: 70204-315
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
CERESIN (UNII: Q1LS2UJO3A)  
SHEA BUTTER (UNII: K49155WL9Y)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70204-315-014.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/30/2020
Labeler - Hit Promotional Products, Inc. (081070202)

Revised: 7/2020