Spf 30 Lip Balm

Spf 30 Lip Balm
SPL v3
SPL
SPL Set ID fe1b3122-b6e2-46fa-e053-6394a90afd59
Route
TOPICAL
Published
Effective Date 2023-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (3.3 g)
Inactive Ingredients
Eugenol Aluminum Hydroxide Hydrogenated Polydecene Type I Limonene, (+)- Methyl Heptine Carbonate Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Coumarin Tocopherol Ursolic Acid Cinnamaldehyde Stearic Acid Cinnamyl Alcohol Hydrogenated Polybutene (1300 Mw) Ethylhexyl Palmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-01
Description

Active Ingredient Purpose Titanium Dioxide 3.32% Sunscreen

Medication Information

Warnings and Precautions

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
Indications and Usage

Stop use and ask a doctor

  • If rash occurs
Dosage and Administration

Directions

  • Apply Liberally and evenly 15 minutes before sun exposure
  • 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 10 am- 2pm
  • Wear long-sleeved shirts, pants, hats & sunglasses
  • Reapply after 40 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours

Description

Active Ingredient Purpose Titanium Dioxide 3.32% Sunscreen

Section 50565-1

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

Section 51727-6

Inactive Ingredients

Hydrogenated Polyisobutene, Ethylhexyl Palmitate, Hydrogenated Styrene/Isoprene Copolymer, Hydrogenated Polydecene, Flavor, Cinnamal, Cinnamyl Alcohol, Coumarin, d-Limonene, Eugenol, Methyl 2 Octynoate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Urolic Acid, Tocopherol, Stearic Acid, Aluminum Hydroxide.

Section 51945-4

(Malin+Goetz)

spf 30 lip balm.

Broad Spectrum Mineral Sunscreen

Water Resistant 40 minutes

0.3fl. oz./10ml

Section 55105-1

Uses

  • 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
Section 55106-9

Active Ingredient Purpose

Titanium Dioxide 3.32% Sunscreen

Section 60561-8

Other information

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

Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor

  • If rash occurs
Dosage and Administration (34068-7)

Directions

  • Apply Liberally and evenly 15 minutes before sun exposure
  • 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 10 am- 2pm
  • Wear long-sleeved shirts, pants, hats & sunglasses
  • Reapply after 40 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours

Warnings and Precautions (34071-1)

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
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 51727-6 (51727-6)

Inactive Ingredients

Hydrogenated Polyisobutene, Ethylhexyl Palmitate, Hydrogenated Styrene/Isoprene Copolymer, Hydrogenated Polydecene, Flavor, Cinnamal, Cinnamyl Alcohol, Coumarin, d-Limonene, Eugenol, Methyl 2 Octynoate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Urolic Acid, Tocopherol, Stearic Acid, Aluminum Hydroxide.

Section 51945-4 (51945-4)

(Malin+Goetz)

spf 30 lip balm.

Broad Spectrum Mineral Sunscreen

Water Resistant 40 minutes

0.3fl. oz./10ml

Section 55105-1 (55105-1)

Uses

  • 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
Section 55106-9 (55106-9)

Active Ingredient Purpose

Titanium Dioxide 3.32% Sunscreen

Section 60561-8 (60561-8)

Other information

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:08.652713 · Updated: 2026-03-14T23:10:23.192014