Lip Balm SPF

Manufacturer: Harry's, Inc.
Effective date: 2016-04-04
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:45:35

Label at a glance#

ProductLip Balm SPF

Active ingredientOCTINOXATE, ZINC OXIDE

Label structure8 sections

Dosage and administration

• apply liberally 15 minutes before sun exposure • re-apply at least every 2 hours • use a water-resistant sunscreen if swimming or sweating • children under 6 months: ask a doctor

Contacts and useful links#

PhoneLabel contact1-888-212-6855

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Zinc Oxide 6.0%

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 aging. This product has been shown only to help prevent sunburn, not skin cancer or early 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 or irritation 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 • re-apply at least every 2 hours • use a water-resistant sunscreen if swimming or sweating • children under 6 months: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Hydrogenated Coconut Oil, Butyrospermum Parkii (Shea) Butter, Microcrystalline Wax, Beeswax, C12-15 Alkyl Benzoate, C18-C70 Isoparaffin, Myristyl Myristate, Polyethylene, Flavor, Paraffin, Menthyl Lactate, Tocopheryl Acetate, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Oil, Sodium Saccharin, Triethoxycaprylylsilane, Limonene, BHT, Linalool, Cucumis Sativus (Cucumber) Seed Extract, Citric Acid

Other information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-212-6855

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label01Inner Label01

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ZINC CATION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70533-002-57	2020-01-31	C162847	48780-1	9d75b9d0-77b3-f424-e053-dadaa90a57ce	Lip Balm SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70533-002-57	Lip Balm SPF	1 in 1 CARTON	STICK	1		2
70533-002-57	Lip Balm SPF	5.7 g in 1 TUBE	STICK	5.7		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70533-002	LIP BALM SPF (OCTINOXATE, ZINC OXIDE) STICK [HARRY'S, INC.]	2	Legacy NDC, 2 package rows	20160404_4e9784cf-ea7d-42e5-952c-27585f8614e6.zip

Products#

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

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

Lip Balm SPF
OCTINOXATE, ZINC OXIDE
HYDROGENATED COCONUT OIL
SHEA BUTTER
MICROCRYSTALLINE WAX
YELLOW WAX
ALKYL (C12-15) BENZOATE
MYRISTYL MYRISTATE
HIGH DENSITY POLYETHYLENE
METHYL SALICYLATE
PARAFFIN
MENTHYL LACTATE, (-)-
.ALPHA.-TOCOPHEROL ACETATE
POLYHYDROXYSTEARIC ACID (2300 MW)
SUNFLOWER OIL
SACCHARIN SODIUM
TRIETHOXYCAPRYLYLSILANE
BUTYLATED HYDROXYTOLUENE
LINALOOL, (+/-)-
CUCUMBER SEED
CITRIC ACID MONOHYDRATE
OCTINOXATE
ZINC OXIDE
ZINC CATION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70533-002	70533-002-57

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYDROGENATED COCONUT OIL	JY81OXM1OM	IACT
SHEA BUTTER	K49155WL9Y	IACT
MICROCRYSTALLINE WAX	XOF597Q3KY	IACT
YELLOW WAX	2ZA36H0S2V	IACT
ALKYL (C12-15) BENZOATE	A9EJ3J61HQ	IACT
MYRISTYL MYRISTATE	4042ZC00DY	IACT
HIGH DENSITY POLYETHYLENE	UG00KM4WR7	IACT
METHYL SALICYLATE	LAV5U5022Y	IACT
PARAFFIN	I9O0E3H2ZE	IACT
MENTHYL LACTATE, (-)-	2BF9E65L7I	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
POLYHYDROXYSTEARIC ACID (2300 MW)	YXH47AOU0F	IACT
SUNFLOWER OIL	3W1JG795YI	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
TRIETHOXYCAPRYLYLSILANE	LDC331P08E	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
LINALOOL, (+/-)-	D81QY6I88E	IACT
CUCUMBER SEED	BT3S9L53JK	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
OCTINOXATE	4Y5P7MUD51	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIM

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2fab0ad2-7443-53fc-e054-00144ff8d46c			4e9784cf-ea7d-42e5-952c-27585f8614e6	2016-04-04	Warnings	Exact identifier spl id: 2fab0ad2-7443-53fc-e054-00144ff8d46c spl set id: 4e9784cf-ea7d-42e5-952c-27585f8614e6

Reported adverse events (FAERS/openFDA)#

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