Gadis Lip Moisturizer

Manufacturer: Gadis Ingenious Gadgets Inc.
Effective date: 2014-09-09
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:40:10

Label at a glance#

ProductGadis Lip Moisturizer SPF15

Active ingredientOctinoxate, Oxybenzone

Label structure10 sections

Dosage and administration

apply liberally and evenly 15 minutes before sun exposure. 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 ...

Storage and handling

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

Contacts and useful links#

PhoneLabel contact(718) 831-2626

Websitewww.lipbalmring.com

www.LipBalmRing.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7%
Oxybenzone 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

Helps prevent sunburn
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally and evenly 15 minutes before sun exposure.
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
Reapply:
After 40 minutes swimming or
sweating
Immediately after towel drying
At least every 2 hours
Children under 6 months of age: Ask
a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

sunflower oil, olive

oil, beeswax, candelilla wax, carnauba

wax, octyl methoxycinnamate, shea oil,

macadamia oil, fragrance, tocopherol

acetate

SPL UNCLASSIFIED SECTION

Manufactured for

Gadi's Ingenious Gadgets Inc.

Brooklyn NY 11218

(718) 831-2626

www.LipBalmRing.com

Made in China

Designed in the U.S.

Gadis Lip Moisturizer SPF 15

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

gadi's

Lip Moisturizer Ring

Sunscreen Broad Spectrum SPF 15

Water Resistant (40 minutes)

MOISTURIZES, SOOTHES,

AND HYDRATES DRY LIPS.

RECOMMENDED FOR USE

DURING OUTDOOR SPORTS.

4 RING INSERTS

NET WT. 0.1 OZ (2.8 G)

Front2

Front

Back

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69065-001-02	2019-11-27	C162847	48780-1	9855e2a2-3bfd-60a7-e053-dbdaa90a05bd	Gadis Lip Moisturizer SPF 15
69065-001-04	2019-11-27	C162847	48780-1	9855e2a2-3bfd-60a7-e053-dbdaa90a05bd	Gadis Lip Moisturizer SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69065-001-02	Gadis Lip MoisturizerSPF15	1.4 g in 1 CARTON	LIPSTICK	1.4		2
69065-001-04	Gadis Lip MoisturizerSPF15	2.8 g in 1 CARTON	LIPSTICK	2.8		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69065-001	GADIS LIP MOISTURIZER SPF15 (OCTINOXATE AND OXYBENZONE) LIPSTICK [GADIS INGENIOUS GADGETS INC.]	2	Legacy NDC, 2 package rows	20140909_02f768aa-9369-49c8-9a68-6fb7b85b6b18.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	2
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	2
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	2
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	2
2-BUTYLOCTYL METHACRYLATE	INACTIVE INGREDIENT	C927XK2YP0	2
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	2
MACADAMIA OIL	INACTIVE INGREDIENT	515610SU8C	2
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	2
SHEANUT OIL	INACTIVE INGREDIENT	O88E196QRF	2
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	2
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Gadis Lip Moisturizer SPF15
Octinoxate and Oxybenzone
Octinoxate
Oxybenzone
SUNFLOWER OIL
OLIVE OIL
YELLOW WAX
CANDELILLA WAX
2-BUTYLOCTYL METHACRYLATE
SHEANUT OIL
MACADAMIA OIL
CARNAUBA WAX

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69065-001	69065-001-02, 69065-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Octinoxate	4Y5P7MUD51	ACTIB
Oxybenzone	95OOS7VE0Y	ACTIB
SUNFLOWER OIL	3W1JG795YI	IACT
OLIVE OIL	6UYK2W1W1E	IACT
YELLOW WAX	2ZA36H0S2V	IACT
CANDELILLA WAX	WL0328HX19	IACT
2-BUTYLOCTYL METHACRYLATE	C927XK2YP0	IACT
SHEANUT OIL	O88E196QRF	IACT
MACADAMIA OIL	515610SU8C	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 29 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	140 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	CAPSULE, EXTENDED RELEASE / ORAL		288 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, COATED / ORAL	207.5 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET, FILM COATED / ORAL	0.8 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, COATED / ORAL	213.7 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CAPSULE, EXTENDED RELEASE / ORAL	80.67 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	GUM, CHEWING / BUCCAL		10 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOLUTION / ORAL	425 mg/1ml		Exact identifier — unii candidate 5 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	LOTION / TOPICAL		32468 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET / ORAL	3.22 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, DELAYED RELEASE / ORAL	230 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	CAPSULE / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOLUTION / TOPICAL	0.6 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOAP / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET / ORAL		4 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, DELAYED RELEASE / ORAL	0.1 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CAPSULE / ORAL		44 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	CAPSULE / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, EXTENDED RELEASE / ORAL		2150 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates

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
24aa1424-21f1-465e-a047-84ab3569b959			02f768aa-9369-49c8-9a68-6fb7b85b6b18	2014-09-09	Warnings	Exact identifier spl id: 24aa1424-21f1-465e-a047-84ab3569b959 spl set id: 02f768aa-9369-49c8-9a68-6fb7b85b6b18

Reported adverse events (FAERS/openFDA)#

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