Vanilla Lip Balm

Vanilla Lip Balm
SPL v3
SPL
SPL Set ID d27398d3-98b0-4f70-997e-6ed02559594f
Route
TOPICAL
Published
Effective Date 2022-09-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.0 g) Octinoxate (6.5 g) Octisalate (5.0 g) Octocrylene (1.5 g)
Inactive Ingredients
Sunflower Oil Yellow Wax Olive Oil Cannabis Sativa Seed Oil Rosemary Oil .alpha.-tocopherol Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-06

Description

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


Medication Information

Warnings and Precautions

Warnings

For external use onlyDo not use on damaged or broken

skin • Stop use and ask a doctor if• rash occurs • When

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

Indications and Usage

Uses: Helps prevent sunburn

Dosage and Administration

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 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 protection measures including: • limit time in the sun, especially from

10a.m. - 2p.m.• wear long sleeved shirts, pants, hat, 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 medilcal

help or contact a Poison Control center right away.

Section 51727-6

Inactive ingredients: Sunflower oil, beeswax, extra virgin olive

oil, flavor, hemp seed oil, rosemary extract, vitamin E, aloe vera.

Section 51945-4

Broad Spectrum SPF 15 Sunscreen

Vanilla Lip Balm

Net Wt. 0.15 oz (4.25g)

SAFETY SEAL

Dist. by: www.totallypromotional.com | CoIdwater, OH 45828

res

Section 55105-1

Purpose

Avobenzone ,,,,Sunscreen

Octinoxate ,,,,,,,Sunscreen

Octisalate ,,,,,,,,Sunscreen

Octocrylene ,,,,,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 minutes 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 protection measures including: • limit time in the sun, especially from

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

Warnings and Precautions (34071-1)

Warnings

For external use onlyDo not use on damaged or broken

skin • Stop use and ask a doctor if• rash occurs • When

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

Section 50565-1 (50565-1)

Keep out of reach of children:   If swallowed, get medilcal

help or contact a Poison Control center right away.

Section 51727-6 (51727-6)

Inactive ingredients: Sunflower oil, beeswax, extra virgin olive

oil, flavor, hemp seed oil, rosemary extract, vitamin E, aloe vera.

Section 51945-4 (51945-4)

Broad Spectrum SPF 15 Sunscreen

Vanilla Lip Balm

Net Wt. 0.15 oz (4.25g)

SAFETY SEAL

Dist. by: www.totallypromotional.com | CoIdwater, OH 45828

res

Section 55105-1 (55105-1)

Purpose

Avobenzone ,,,,Sunscreen

Octinoxate ,,,,,,,Sunscreen

Octisalate ,,,,,,,,Sunscreen

Octocrylene ,,,,,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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