Sun X 50 Lip Balm

SPL v6

SPL

SPL Set ID c0355990-b842-47cd-e053-2a95a90a7c82

Route

TOPICAL

Published

Effective Date 2023-03-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Petrolatum (40 g) Octisalate (5 g) Octinoxate (7.5 g) Avobenzone (3 g) Homosalate

Inactive Ingredients

Mineral Oil White Wax Alkyl (c12-15) Benzoate Coconut Oil Phenyl Trimethicone Tocopherol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-01-01

Description

Avobenzone…3.0% Homosalate…3.0% Octinoxate......7.5% Octisalate…...5.0% Petrolatum....40.0%

Purpose

Sunscreen Sunscreen Sunscreen Sunscreen Skin Protectant

Medication Information

Purpose

Sunscreen

Skin Protectant

Description

Avobenzone…3.0% Homosalate…3.0% Octinoxate......7.5% Octisalate…...5.0% Petrolatum....40.0%

Uses

Helps protect against sunburn and chapped lips.

Warnings

Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging , skin cancer, and other harmful effects of the sun.

Questions?

1.877.684.5774

Directions:

Apply liberally before sun exposure and as needed.

Children under 6 months of age: Ask a doctor before use.

Other Information:

protect the product in this container from excessive heat and direct sun.

Active Ingredients:

Avobenzone…3.0%

Homosalate…3.0%

Octinoxate......7.5%

Octisalate…...5.0%

Petrolatum....40.0%

Inactive Ingredients

C12-15 alkyl benzoate, caprylic/capric triglyceride, mineral oil, ozokerite, phenyl trimethicone, tocopherol

Stop Use and Ask A Doctor

if rash or irritation develops and lasts.

Sunx 50 Lip Balm 65753 108

Keep Out of Reach of Children.

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

Structured Label Content

Uses

Helps protect against sunburn and chapped lips.

Purpose

Sunscreen

Skin Protectant

Warnings

Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging , skin cancer, and other harmful effects of the sun.

Questions?

1.877.684.5774

Directions:

Apply liberally before sun exposure and as needed.

Children under 6 months of age: Ask a doctor before use.

Other Information: (Other information:)

protect the product in this container from excessive heat and direct sun.

Active Ingredients:

Avobenzone…3.0%

Homosalate…3.0%

Octinoxate......7.5%

Octisalate…...5.0%

Petrolatum....40.0%

Inactive Ingredients

C12-15 alkyl benzoate, caprylic/capric triglyceride, mineral oil, ozokerite, phenyl trimethicone, tocopherol

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash or irritation develops and lasts.

Sunx 50 Lip Balm 65753 108 (SunX 50 Lip Balm 65753-108)

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "40", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "7.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WHITE WAX", "unii": "7G1J5DA97F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALKYL (C12-15) BENZOATE", "unii": "A9EJ3J61HQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCONUT OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENYL TRIMETHICONE", "unii": "DR0K5NOJ4R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps protect against sunburn and chapped lips.", "Purpose": "Sunscreen Sunscreen Sunscreen Sunscreen Skin Protectant", "Warnings": "Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging , skin cancer, and other harmful effects of the sun.", "Questions?": "1.877.684.5774", "Directions:": "Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.", "Other information:": "protect the product in this container from excessive heat and direct sun.", "Active Ingredients:": "Avobenzone…3.0% Homosalate…3.0% Octinoxate......7.5% Octisalate…...5.0% Petrolatum....40.0%", "Inactive Ingredients": "C12-15 alkyl benzoate, caprylic/capric triglyceride, mineral oil, ozokerite, phenyl trimethicone, tocopherol", "Stop use and ask a doctor": "if rash or irritation develops and lasts.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:28.760637 · Updated: 2026-03-14T23:02:03.345038