84090-005-01. Pure Sol Spf 30 Lip Balm Cacoa Butter—solid-5g

84090-005-01. Pure Sol Spf 30 Lip Balm Cacoa Butter—solid-5g
SPL v1
SPL
SPL Set ID 40537561-d334-5859-e063-6394a90a92a7
Route
TOPICAL
Published
Effective Date 2025-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (7.68 g)
Inactive Ingredients
Microcrystalline Wax Butylene Glycol Hydroxyacetophenone Candelilla Cera Ethylhexyl Palmitate Ci 15985 Pegzerepoetin Alfa Paraffin Synthetic Wax (1900 Mw) Tridecyl Trimellitate .alpha.-tocopherol Acetate Diisostearyl Malate Hydrogenated Coconut Oil Theobroma Cacao (cocoa) Seed Butter Hydrogenated Polyisobutene (450 Mw) Prunus Amygdalus Dulcis (sweet Almond) Oil Ci 19140 Mineral Oil Triethoxycaprylylsilane Caprylic/capric Triglyceride Phenoxyethanol Ethylhexylglycerin Helianthus Annuus (sunflower) Seed Oil Honey

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-04

Description

Zinc Oxide 7.68%


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

Apply liberally 15 minutes before sun exposure

- Reapply Liberally as often as necessary.

- 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 broad spectrum SPF of 15 or higher and other sun protection measures

Dosage and Administration

limit time in the sun, especially from 10 a.m. - 2 p.m.

- wear long-sleeve shirts, pants, hats, and sunglasses

- Reapply at least every 2 hours

- Use a water resistant sunscreen if swimming or sweating

Description

Zinc Oxide 7.68%

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or

contact a Poison Control Center right away.

Section 51727-6

MINERAL OIL

ETHYLHEXYL PALMITATE

CERA

PARAFFIN

TRIETHOXYCAPRYLYLSILANE

MICROCRYSTALLINE WAX

SYNTHETIC WAX

TRIDECYL TRIMELLITATE

POLYISOBUTENE

CAPRYLIC/CAPRIC TRIGLYCERIDE

HYDROGENATED COCONUT OIL

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

DIISOSTEARYL MALATE

CANDELILLA CERA

THEOBROMA CACAO (COCOA) SEED BUTTER

TOCOPHERYL ACETATE

HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL

PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL

WATER

HONEY EXTRACT

BUTYLENE GLYCOL

HYDROXYACETOPHENONE

CI 19140

CI 15985

Section 51945-4

Section 55105-1

-Helps prevent and temporarily chafed,chapped, cracked, or windburned skin and/or lips.

-helps prevent sunburn

Section 55106-9

Zinc Oxide 7.68%


Structured Label Content

Indications and Usage (34067-9)

Apply liberally 15 minutes before sun exposure

- Reapply Liberally as often as necessary.

- 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 broad spectrum SPF of 15 or higher and other sun protection measures

Dosage and Administration (34068-7)

limit time in the sun, especially from 10 a.m. - 2 p.m.

- wear long-sleeve shirts, pants, hats, and sunglasses

- Reapply at least every 2 hours

- Use a water resistant sunscreen if swimming or sweating

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 product is swallowed, get medical help or

contact a Poison Control Center right away.

Section 51727-6 (51727-6)

MINERAL OIL

ETHYLHEXYL PALMITATE

CERA

PARAFFIN

TRIETHOXYCAPRYLYLSILANE

MICROCRYSTALLINE WAX

SYNTHETIC WAX

TRIDECYL TRIMELLITATE

POLYISOBUTENE

CAPRYLIC/CAPRIC TRIGLYCERIDE

HYDROGENATED COCONUT OIL

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

DIISOSTEARYL MALATE

CANDELILLA CERA

THEOBROMA CACAO (COCOA) SEED BUTTER

TOCOPHERYL ACETATE

HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL

PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL

WATER

HONEY EXTRACT

BUTYLENE GLYCOL

HYDROXYACETOPHENONE

CI 19140

CI 15985

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

-Helps prevent and temporarily chafed,chapped, cracked, or windburned skin and/or lips.

-helps prevent sunburn

Section 55106-9 (55106-9)

Zinc Oxide 7.68%


Advanced Ingredient Data


Raw Label Data

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