Broad Spectrum Spf 15 Sunscreen Lip Balm

Broad Spectrum Spf 15 Sunscreen Lip Balm
SPL v1
SPL
SPL Set ID 6dcbb2cd-e690-4970-8cf1-08ca539d3602
Route
TOPICAL
Published
Effective Date 2025-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (0.085 g) Ethylhexyl Methoxycinnamate (0.28 g) Octisalate (0.21 g) Octocrylene (0.06 g)
Inactive Ingredients
Sunflower Oil Beeswax Olive Oil Tocopherol Cannabis Sativa Seed Oil Rosemary Aloe Soybean Oil Canola Oil Sunflower Oil Mono/diglycerides

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-23

Description

​Drug Facts Active Ingredients :    Avobenzone 2.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%


Medication Information

Warnings and Precautions

​Drug Facts ​(continued)

Warnings

For external use only.

Indications and Usage

Uses • Helps prevent sunburn

Dosage and Administration

Directions: •Apply liberally 15 mintues before sun exposure. •Use a water resistant sunscreen if swimming or sweating. •Reapply at least every 2 hours. •Children under 6 months of age: 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

10a.m. - 2p.m. • wear long sleeved shirts, pants, hats, and sunglasses.

Description

​Drug Facts Active Ingredients :    Avobenzone 2.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%

Section 50565-1

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

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50569-3

•Stop use and ask doctor if •rash occurs•

Section 50570-1

•Do not use on damaged or broken skin

Section 51727-6

Inactive Ingredients: Sunflower Oil*, Beeswax, Olive Oil*,

Flavor, Tocopherol, Hemp Seed Oil*, Rosemary Extract, Aloe

Extract, Soybean Oil, Canola Oil, Sunflower Seed Oil Glycerides.

*Organic Ingredient

Section 51945-4

Apple Lip Balm

With Aloe Vera 

​Durvet®

​www.durvet.com

​Broad Spectrum SPF 15 Sunscreen

Net Wt. .15 oz                                   ​NDC ​30798-418-99

Dist. by: Durvet, Inc. Blue Springs, MO 64014

816-229-9101                        lSS25XB08

RES

Section 55105-1

Purpose

Sunscreen

Section 55106-9

​Drug Facts

Active Ingredients:   

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Section 60561-8

Other Information: ​Protect this product from excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)

Uses • Helps prevent sunburn

Dosage and Administration (34068-7)

Directions: •Apply liberally 15 mintues before sun exposure. •Use a water resistant sunscreen if swimming or sweating. •Reapply at least every 2 hours. •Children under 6 months of age: 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

10a.m. - 2p.m. • wear long sleeved shirts, pants, hats, and sunglasses.

Warnings and Precautions (34071-1)

​Drug Facts ​(continued)

Warnings

For external use only.

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50569-3 (50569-3)

•Stop use and ask doctor if •rash occurs•

Section 50570-1 (50570-1)

•Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Inactive Ingredients: Sunflower Oil*, Beeswax, Olive Oil*,

Flavor, Tocopherol, Hemp Seed Oil*, Rosemary Extract, Aloe

Extract, Soybean Oil, Canola Oil, Sunflower Seed Oil Glycerides.

*Organic Ingredient

Section 51945-4 (51945-4)

Apple Lip Balm

With Aloe Vera 

​Durvet®

​www.durvet.com

​Broad Spectrum SPF 15 Sunscreen

Net Wt. .15 oz                                   ​NDC ​30798-418-99

Dist. by: Durvet, Inc. Blue Springs, MO 64014

816-229-9101                        lSS25XB08

RES

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

​Drug Facts

Active Ingredients:   

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Section 60561-8 (60561-8)

Other Information: ​Protect this product from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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