Broad Spectrum SPF 15 Lip Balm

Broad Spectrum SPF 15 Lip Balm by

Drug Labeling and Warnings

Broad Spectrum SPF 15 Lip Balm by is a Otc medication manufactured, distributed, or labeled by Hit Promotional Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BROAD SPECTRUM SPF 15 LIP BALM- octocrylene, octyl salicylate stick 
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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Broad Spectrum SPF 15 Lip Balm

Active ingredients

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

Purpose

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 Lip Balm)

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

Other information

Protect from excessive heat and direct sun.

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

Label

BROAD SPECTRUM SPF 15 LIP BALM 
octocrylene, octyl salicylate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70204-317
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70204-317-01	4.5 g in 1 TUBE; Type 0: Not a Combination Product	04/30/2020
2	NDC: 70204-317-02	0.2 g in 1 TUBE; Type 0: Not a Combination Product	04/30/2020	07/10/2020
3	NDC: 70204-317-03	2.0 g in 1 TUBE; Type 0: Not a Combination Product	04/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/30/2020

Labeler - Hit Promotional Products, Inc. (081070202)

Revised: 7/2020

Document Id: c28233e9-dd52-4f2b-a3e7-c841dc45af83

34390-5

Set id: 4c6d74d6-4465-4080-bfb8-94da0a180c49

Version: 2

Effective Time: 20200712