Lip Balm Unflavored Spf 30

Lip Balm Unflavored Spf 30
SPL v6
SPL
SPL Set ID b55a0bd0-2a32-2977-e053-2a95a90aa142
Route
TOPICAL
Published
Effective Date 2020-08-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (5 g) Octisalate (3 g) Avobenzone (2.5 g)
Inactive Ingredients
Castor Oil Cetostearyl Alcohol Lauryl Laurate Olive Oil Hydrogenated Castor Oil Yellow Wax Carnauba Wax Hydrogenated Soybean Oil Candelilla Wax Glyceryl Stearate Se Phenethyl Benzoate Coconut Octyldodecyl Neopentanoate Cetyl Dimethicone 150 Hippophae Rhamnoides Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-03
Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses
  • helps prevent sunburn
  • helps prevent chapped or cracked skin
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if rash occurs

Warnings

For external use only *Keep out of eyes

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months: Ask a doctor
Active Ingredients

Octocrylene 5.0%

Octisalate 3.0%

Avobenzone 2.5%

Inactive Ingredients

ricinus communis (castor) seed oil, cetearyl alcohol, lauryl laurate, olea europaea (olive) fruit oil, hydrogenated castor oil, beeswax, copernicia cerifera (carnauba) wax, flavor, hydrogenated soybean oil, euphorbia cerifera (candelilla) wax, flavor, glyceryl stearate, octyl dodecyl citrate crosspolymer, phenethyl benzoate, cocos nucifera (coconut) fruit extract, octyldodecyl neopentanoate, cetyl dimethicone, hippophae rhamnoides (sea buckthorn) oil.

Principal Display Panel Label

4.44g NDC 52854-927-01

4.44g NDC 52854-927-01 Blister Card Front

4.44g NDC 52854-927-01 Blister Card Back

Structured Label Content

Uses
  • helps prevent sunburn
  • helps prevent chapped or cracked skin
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Purpose

Sunscreen

Warnings

For external use only *Keep out of eyes

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months: Ask a doctor
Active Ingredients

Octocrylene 5.0%

Octisalate 3.0%

Avobenzone 2.5%

Inactive Ingredients

ricinus communis (castor) seed oil, cetearyl alcohol, lauryl laurate, olea europaea (olive) fruit oil, hydrogenated castor oil, beeswax, copernicia cerifera (carnauba) wax, flavor, hydrogenated soybean oil, euphorbia cerifera (candelilla) wax, flavor, glyceryl stearate, octyl dodecyl citrate crosspolymer, phenethyl benzoate, cocos nucifera (coconut) fruit extract, octyldodecyl neopentanoate, cetyl dimethicone, hippophae rhamnoides (sea buckthorn) oil.

Principal Display Panel Label (Principal Display Panel - Label)

4.44g NDC 52854-927-01

4.44g NDC 52854-927-01 Blister Card Front

4.44g NDC 52854-927-01 Blister Card Back

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:11.928238 · Updated: 2026-03-14T23:13:23.763125