Reefsafe Baby And Toddlers Sunscreen Spf50

SPL v1

SPL

SPL Set ID 44dd513e-ebaa-0d6a-e063-6394a90a78b7

Route

TOPICAL

Published

Effective Date 2025-11-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (25 kg)

Inactive Ingredients

Coco-caprylate/caprate Sodium Chloride Polyglyceryl-3 Ricinoleate Xanthan Gum Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Coconut Alkanes Helianthus Annuus (sunflower) Seed Oil Alpha-tocopherol Acetate Water Polyhydroxystearic Acid (2300 Mw) Isostearic Acid Candelilla Wax Glyceryl Stearate Citrate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-11-30

Description

Zinc oxide - 25%

Medication Information

Warnings and Precautions

For external use only.

Do not use on damaged r broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

kindly refer to label picture

Dosage and Administration

Kindly refer to Label

Description

Zinc oxide - 25%

Section 50565-1

Keep out of reach of children.

Section 51727-6

See ingredients on label

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Zinc oxide - 25%

Structured Label Content

Indications and Usage (34067-9)

kindly refer to label picture

Dosage and Administration (34068-7)

Kindly refer to Label

Warnings and Precautions (34071-1)

For external use only.

Do not use on damaged r broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

See ingredients on label

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc oxide - 25%

Advanced Ingredient Data

[{"name": "COCO-CAPRYLATE/CAPRATE", "unii": "8D9H4QU99H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYGLYCERYL-3 RICINOLEATE", "unii": "MZQ63P0N0W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCONUT ALKANES", "unii": "1E5KJY107T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL", "unii": "3W1JG795YI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALPHA-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYHYDROXYSTEARIC ACID (2300 MW)", "unii": "YXH47AOU0F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOSTEARIC ACID", "unii": "X33R8U0062", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CANDELILLA WAX", "unii": "WL0328HX19", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL STEARATE CITRATE", "unii": "WH8T92A065", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "100", "strengthNumeratorUnit": "kg", "strengthDenominatorUnit": "kg"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "kindly refer to label picture", "34068-7": "Kindly refer to Label", "34071-1": "For external use only. Do not use on damaged r broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.", "50565-1": "Keep out of reach of children.", "51727-6": "See ingredients on label", "55105-1": "Sunscreen", "55106-9": "Zinc oxide - 25%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:24.193950 · Updated: 2026-03-14T23:10:48.259693