Reef Safe Lip Balm

Reef Safe Lip Balm
SPL v1
SPL
SPL Set ID 486930f2-026b-14b4-e063-6394a90aa031
Route
TOPICAL
Published
Effective Date 2025-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (3 g) Homosalate (5 g) Avobenzone (2 g) Octisalate
Inactive Ingredients
Petrolatum Triethoxycaprylylsilane Bht Mineral Oil Beeswax Tocopherol Ceresin Phenoxyethanol Fragrance 13576 Polyisobutylene (1000 Mw) Cocos Nucifera (coconut) Oil Olea Europaea (olive) Fruit Oil Butyrospermum Parkii (shea) Butter Tridecyl Trimellitate Microcrystalline Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-15

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Warnings and Precautions

For external use only

Purpose

Sunscreen

Description

Drug Facts

Uses
  • Helps prevent sunburn
  • Helps prevent and temporarily protect dry, chapped or windblown lips.
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor: if rash or irritation develops and persists.

Section 51945-4

Directions

Apply librerally before sun exposure and as needed.

Children under 6 months or age: ask a doctor before use.

Questions?

Tekweld 45 Rabro Dr.Hauppauge, NY 11788

www.tekweld.com

Active Ingredients

Avobenzone 2%

Homosalate 5%

Octisalate 3%

Octocrylene 3%

Inactive Ingredients

Mineral Oil,Ozokerite, Petrolatum, Triethoxycaprylylsilane, Microcrystalline Wax, Beeswax, Tridecyl Trimellitate, Cocos Nucifera (Coconut) Oil,Olea Europaea (Olive) Fruit Oil,Polyisobutene, Butyrospermum Parkii (Shea) Butter, Tocopherol, Phenoxyethanol,Fragrance, BHT

Skin Cancer/ Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not cancer or early aging.


Structured Label Content

Uses
  • Helps prevent sunburn
  • Helps prevent and temporarily protect dry, chapped or windblown lips.
Warnings and Precautions (34071-1)

For external use only

Section 42229-5 (42229-5)

Drug Facts

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 50566-9 (50566-9)

Stop use and ask a doctor: if rash or irritation develops and persists.

Section 51945-4 (51945-4)

Purpose

Sunscreen

Directions

Apply librerally before sun exposure and as needed.

Children under 6 months or age: ask a doctor before use.

Questions?

Tekweld 45 Rabro Dr.Hauppauge, NY 11788

www.tekweld.com

Active Ingredients (Active ingredients)

Avobenzone 2%

Homosalate 5%

Octisalate 3%

Octocrylene 3%

Inactive Ingredients (Inactive ingredients)

Mineral Oil,Ozokerite, Petrolatum, Triethoxycaprylylsilane, Microcrystalline Wax, Beeswax, Tridecyl Trimellitate, Cocos Nucifera (Coconut) Oil,Olea Europaea (Olive) Fruit Oil,Polyisobutene, Butyrospermum Parkii (Shea) Butter, Tocopherol, Phenoxyethanol,Fragrance, BHT

Skin Cancer/ Skin Aging Alert (Skin cancer/ skin aging alert)

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not cancer or early aging.


Advanced Ingredient Data


Raw Label Data

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