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SPL v1

SPL

SPL Set ID 286f7e2f-94d2-22b5-e063-6394a90a3ad5

Route

CUTANEOUS

Published

Effective Date 2024-12-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Butyrospermum Parkii (shea) Butter (100 mg)

Inactive Ingredients

Beeswax Phenoxyethanol Tocopherol Caprylic/capric Triglyceride Simmondsia Chinensis (jojoba) Seed Oil Magnesium Hydroxide Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-12-04

Description

avoid danger of suffocation, keep this bag away from babies and children.

Medication Information

Warnings and Precautions

avoid danger of suffocation, keep this bag away from babies and children.

Indications and Usage

Releases a long-lasting fragrance on the skin.

creating a pleasant aroma around the body

Dosage and Administration

Apply 1-2 times a day

Description

avoid danger of suffocation, keep this bag away from babies and children.

Section 50566-9

Stop use and ask doctor if rash occurs.

Section 50567-7

Do not apply to wounds or damaged skin.

Section 51727-6

Caprylic/Capric Triglyceride

Glycerin

Beeswax

Ozokerite

Simmondsia Chinensis (Jojoba) Seed Oil

Fragrance

Phenoxyethanol

Tocopherol

Section 51945-4

Section 55105-1

Deodorant

Section 55106-9

BUTYROSPERMUM PARKII (SHEA) BUTTER

Structured Label Content

Indications and Usage (34067-9)

Releases a long-lasting fragrance on the skin.

creating a pleasant aroma around the body

Dosage and Administration (34068-7)

Apply 1-2 times a day

Warnings and Precautions (34071-1)

avoid danger of suffocation, keep this bag away from babies and children.

Section 50566-9 (50566-9)

Stop use and ask doctor if rash occurs.

Section 50567-7 (50567-7)

Do not apply to wounds or damaged skin.

Section 51727-6 (51727-6)

Caprylic/Capric Triglyceride

Glycerin

Beeswax

Ozokerite

Simmondsia Chinensis (Jojoba) Seed Oil

Fragrance

Phenoxyethanol

Tocopherol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Deodorant

Section 55106-9 (55106-9)

BUTYROSPERMUM PARKII (SHEA) BUTTER

Advanced Ingredient Data

[{"name": "BEESWAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYROSPERMUM PARKII (SHEA) BUTTER", "unii": "K49155WL9Y", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CAPRYLIC/CAPRIC TRIGLYCERIDE", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL", "unii": "724GKU717M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM HYDROXIDE", "unii": "NBZ3QY004S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Releases a long-lasting fragrance on the skin. creating a pleasant aroma around the body", "34068-7": "Apply 1-2 times a day", "34071-1": "avoid danger of suffocation, keep this bag away from babies and children.", "50566-9": "Stop use and ask doctor if rash occurs.", "50567-7": "Do not apply to wounds or damaged skin.", "51727-6": "Caprylic/Capric Triglyceride Glycerin Beeswax Ozokerite Simmondsia Chinensis (Jojoba) Seed Oil Fragrance Phenoxyethanol Tocopherol", "55105-1": "Deodorant", "55106-9": "BUTYROSPERMUM PARKII (SHEA) BUTTER"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:46.966162 · Updated: 2026-03-14T23:05:45.354656