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SPF15 lip balm 01 drug information

OCTOCRYLENE, OCTISALATE
Cosmuses Cosmetics (Ningbo) Co., Ltd. · TOPICAL

Product NDC: 82953-009

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameOCTOCRYLENE, OCTISALATE
Labeler / manufacturerCosmuses Cosmetics (Ningbo) Co., Ltd.
RouteTOPICAL
Drug classDrug class not supplied in source label
Product NDC82953-009
Label effective date2026-09-08

Official product label reference

SPF15 lip balm 01 — Cosmuses Cosmetics (Ningbo) Co., Ltd.

This page contains 12 source sections for OCTOCRYLENE, OCTISALATE, topical route. Label set f8695305-b89d-c21c-e053-6394a90a0e84, version 5.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Uses Helps prevent sunburn Higher SPF gives more sunburn protection

Purpose

Purpose Sunscreen
Dosage and administration — label text
Directions Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours Children under 6 months: ask a doctor 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10a.m.- 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses
Warnings
warnings For external use only.
Unclassified section
Drug facts
Active ingredient
Active Ingredients Octocrylene 2% Octisalate 2%
Do not use
Do not use on damaged or broken skin.
While using this medicine
When using this product keep out of eyes. Rinse with water to remove.
When to stop use and seek help
Stop use and ask a doctor if rash occurs.
Child safety
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Inactive ingredient
Inactive Ingredients Paraffinum liquidum, Petrolatum, Ozokerite, Polyisobutene, Ethylhexyl Palmitate, Beeswax, Butyrospermum Parkii (Shea) Butter, Microcrystalline Wax, Phenoxyethanol, Fragrance, BHT
Storage and handling
Other information Protect from excessive heat and direct sun.

Official sources and product identifiers

Substances listed: OCTOCRYLENE, OCTISALATE

Package NDC codes

82953-009-01, 82953-009-02, 82953-009-03, 82953-009-04, 82953-009-05, 82953-009-06, 82953-009-07, 82953-009-08, 82953-009-09, 82953-009-10, 82953-009-11

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.