SPF15 LIP BALM

Manufacturer
Yuyao Jessie Commodity Co.,Ltd.
Effective date
2022-03-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:05:42

Label at a glance#

ProductSPF15 LIP BALM
Active ingredientOCTISALATE, OCTOCRYLENE
Label structure7 sections

Dosage and administration

Apply lberallyly 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every two hours. Children under 6 months: Ask a doctor. Sunprotection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regulaly use a sunscreen with a Broad SpectumSPFof 15 or higher and other sunprotectionmeasures icluding;Limi...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 8%, Octyl Salicylate 4%

OTC - PURPOSE SECTION

sunscreen

USE

INDICATIONS & USAGE SECTION

Helps prevent sunbum.Higher SPF gives more sunbum protection.

If used as directed with other sun protection measures (see Directions). decreases the risk of skin cancer and earty skin aging caused
by the sun.

Warnings

WARNINGS SECTION

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes

Rinse with water to remove

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children,if swallowed,get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply lberallyly 15 minutes before sun exposure.
Use a water resistant sunscreen if swimming or sweating.
Reapply at least every two hours.
Children under 6 months: Ask a doctor.
Sunprotection Measures. Spending time in the sun increases your risk of skin cancer and early skin
aging. To decrease this risk, regulaly use a sunscreen with a Broad SpectumSPFof 15 or higher and other
sunprotectionmeasures icluding;Limit time in the sun, especilly from 10am-2p.m.Wear
long-sleewed shirts, pants, hats, and sunglasses.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mineral oil, Petrolatum, Ozokerite, Polyisobutylene, Butyrospermum Parki Butter, Bees wax,
Cera Microcristallina, Phenoxyethanol, Fragrance, Tocopheryl Acetate
MAY CONTAIN: RED 40 CI 16035 ,BLUE 1 CI 42090, ELLOW5 CI 19140

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51414-910-012022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-022022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-032022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-042022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-052022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-062022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-072022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-082022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-092022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-102022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-112022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-122022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-132022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-142022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-152022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-162022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-172022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-182022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-192022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-202022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-212022-03-19C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-012022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-022022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-032022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-042022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-052022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-062022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-072022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-082022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-092022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-102022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-112022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-122022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-132022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-142022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-152022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-162022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-172022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-182022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-192022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-202022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM
51414-910-212022-01-28C16284748780-1d6a99b39-64b5-a426-e053-dadaa90af4c251414-910 SPF15 LIP BALM

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
da8b04ef-9499-f29e-e053-2995a90a8405a5ceca1d-66af-20d6-e053-2a95a90a1fdb2022-03-18WarningsExact identifier
spl id: da8b04ef-9499-f29e-e053-2995a90a8405
spl set id: a5ceca1d-66af-20d6-e053-2a95a90a1fdb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.