SPL v1
SPL
SPL Set ID 48f1ee5c-33d0-818c-e063-6294a90a1e59
Route
TOPICAL
Published
Effective Date 2026-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Butyl Methoxydibenzoylmethane (1 g) Ethylhexyl Salicylate (3 g)
Inactive Ingredients
Ceresin Isopropyl Palmitate Ethylhexyl Palmitate Beeswax .alpha.-tocopherol Acetate Diisostearyl Malate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-22

Description

CERESIN ETHYLHEXYL PALMITATE ISOPROPYL PALMITATE BEESWAX DIISOSTEARYL MALATE .ALPHA.-TOCOPHEROL ACETATE


Medication Information

Warnings and Precautions



For external use only. Keep out of reach of children. Avoid contactwith eyes.Discontinue use if signs of irritation or rash occur, Store in a cooand dry place.

Indications and Usage



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.

Dosage and Administration



Clean your lips with water to make sure there are no foreign objects or food residue on your lips. You can also wait for the mouth to dry naturallywith lip balm from left to right from top to bottom slowly spread, after good lip balm, it is best to compress the upper and lower lip to make the lip balm more evenly attached to the mouth.

Description

CERESIN ETHYLHEXYL PALMITATE ISOPROPYL PALMITATE BEESWAX DIISOSTEARYL MALATE .ALPHA.-TOCOPHEROL ACETATE

Section 50565-1



Keep out of reach of children.Do not use on broken skin; avoid contact with eyes.lf product gets into eyes, rinseimmediately with plentyof water.Discontinue use if discomfort occurs

Section 51727-6

CERESIN

ETHYLHEXYL PALMITATE

ISOPROPYL PALMITATE

BEESWAX

DIISOSTEARYL MALATE

.ALPHA.-TOCOPHEROL ACETATE

Section 51945-4

Section 55105-1

Sun protection

Section 55106-9

ETHYLHEXYL SALICYLATE 3%

BUTYL METHOXYDIBENZOYLMETHANE 1%


Structured Label Content

Indications and Usage (34067-9)



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.

Dosage and Administration (34068-7)



Clean your lips with water to make sure there are no foreign objects or food residue on your lips. You can also wait for the mouth to dry naturallywith lip balm from left to right from top to bottom slowly spread, after good lip balm, it is best to compress the upper and lower lip to make the lip balm more evenly attached to the mouth.

Warnings and Precautions (34071-1)



For external use only. Keep out of reach of children. Avoid contactwith eyes.Discontinue use if signs of irritation or rash occur, Store in a cooand dry place.

Section 50565-1 (50565-1)



Keep out of reach of children.Do not use on broken skin; avoid contact with eyes.lf product gets into eyes, rinseimmediately with plentyof water.Discontinue use if discomfort occurs

Section 51727-6 (51727-6)

CERESIN

ETHYLHEXYL PALMITATE

ISOPROPYL PALMITATE

BEESWAX

DIISOSTEARYL MALATE

.ALPHA.-TOCOPHEROL ACETATE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sun protection

Section 55106-9 (55106-9)

ETHYLHEXYL SALICYLATE 3%

BUTYL METHOXYDIBENZOYLMETHANE 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)