Active

Manufacturer
CP Skin Health Group, Inc.
Effective date
2024-02-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:08:39

Label at a glance#

ProductActive SPF 45
Active ingredientOCTOCRYLENE, ZINC OXIDE, OCTISALATE
Label structure9 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply: - after 80 minutes of swimming or sweating - immediately after towel drying - 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 borad specturm SPF value of 15 or higher and other skin pro...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octisalate 4.9%, Octocrylene 8.1%, Zinc Oxide 8%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

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

Warnings

WARNINGS SECTION

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if skin rash occurs.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

Reapply:

- after 80 minutes of swimming or sweating

- immediately after towel drying

- 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 borad specturm SPF value of 15 or higher and other skin protecting measures including:

- limit time in the sun, specially from 10a.m. - 2 p.m.

- weare long-sleeved shirts, pants, hats, and sunglasses

Other information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION


Acrylamide/Sodium Acryloyldimethyltaurate Copolymer
Bisabolol
Butyloctyl Salicylate
C13-14 Alkane
Caffeine
Caprylyl Methicone
Cetearyl Alcohol
Cetearyl Olivate
Cetyl Palmitate
Ethyl Ferulate
Ethylhexyl Methoxycrylene
Ethylhexylglycerin
Isohexadecane
Neopentyl Glycol Diheptanoate
Phenoxyethanol
Polyester-7
Polysorbate 80
Propanediol
Sodium Gluconate
Sorbitan Oleate
Sorbitan Olivate
Sorbitan Palmitate
Styrene/Acrylates Copolymer
Triethoxycaprylylsilane
Water
Xanthan Gum

Questions or comments?

OTC - QUESTIONS SECTION

877.722.7546

Active

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ActiveActive

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68726-264-12ActiveSPF 4585 g in 1 TUBELOTION855
68726-264-37ActiveSPF 457.4 g in 1 TUBELOTION7.45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68726-264ACTIVE SPF 45 (BROAD SPECTRUM) LOTION [CP SKIN HEALTH GROUP, INC.]5Current NDC, Legacy NDC, 2 package rows20240215_b6c3adfb-d20a-1b67-e053-2a95a90a4b4e.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68726-26468726-264-12, 68726-264-37

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Source Document#

Source XML

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
Active SPF 45BROAD SPECTRUMCP Skin Health Group, Inc.b6c3adfb-d20a-1b67-e053-2a95a90a4b4e2024-02-14WarningsExact identifier
ndc (package): 68726-264-37
ndc (package): 68726-264-12
ndc (product): 68726-264
ndc11 (package): 68726026412
ndc11 (package): 68726026437
spl id: 115ad436-b80a-618b-e063-6294a90afad3
spl set id: b6c3adfb-d20a-1b67-e053-2a95a90a4b4e

Reported adverse events (FAERS/openFDA)#

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