FDA.reportPublic FDA data

Powerproof Sunscreen 100

Manufacturer
CMS LAB Inc. | Kolmar Korea Co., Ltd.
Effective date
2017-11-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:52:54

Label at a glance#

ProductPowerproof Sunscreen 100
Active ingredientHomosalate, Octinoxate, Zinc Oxide, Titanium Dioxide
Label structure8 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

- Apply the adequate amount onto the entire face at the last stage of your skin care routine. Re-apply frequently and generously to maintain protection. the palm of the hands and pat lightly with the fingertips. - Apply liberally 15 minutes before sun exposure. - Reapply at least every 2 hours. - Use a water-resistant sunscreen if swimming or sweating. - Children under 6 months of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate (5%)

Octinoxate (5%)

Zinc Oxide (4%)

Titanium Dioxide (2.52%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use when skin is red, inflamed, irritated, or painful

When using this product do not apply on other parts of the body do not use on damaged or broken skin avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water do not apply directly to wound or open cut

Stop use and ask a doctor if Rash or irritation on skin develops and lasts

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

- Apply the adequate amount onto the entire face at the last stage of your skin care routine. Re-apply frequently and generously to maintain protection. the palm of the hands and pat lightly with the fingertips.

- Apply liberally 15 minutes before sun exposure.

- Reapply at least every 2 hours.

- Use a water-resistant sunscreen if swimming or sweating.

- Children under 6 months of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, CYCLOPENTASILOXANE, DISILOXANE, ALCOHOL, METHICONE, DIBUTYL ADIPATE, ALUMINUM HYDROXIDE, STEARIC ACID, DIMETHICONE, DIPROPYLENE GLYCOL, POLYSILICONE-15, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, PROPANEDIOL, 1,2-HEXANEDIOL, PORTULACA OLERACEA EXTRACT, CENTELLA ASIATICA EXTRACT, HOUTTUYNIA CORDATA EXTRACT, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CALCIUM ALUMINUM BOROSILICATE, SACCHARIDE HYDROLYSATE, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, SALVIA HISPANICA SEED EXTRACT, METHYL METHACRYLATE CROSSPOLYMER, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TOCOPHEROL, SILICA, CETEARYL DIMETHICONE CROSSPOLYMER, OCTYLDODECANOL, ECHIUM PLANTAGINEUM SEED OIL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, POLYMETHYLSILSESQUIOXANE, POLYGLYCERYL-6 POLYRICINOLEATE, PEG-10 DIMETHICONE, PANTHENOL, SODIUM CHLORIDE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ROSE FLOWER OIL, JUNIPERUS MEXICANA OIL, HYDROGENATED LECITHIN, CERAMIDE 3 (CERAMIDE NP), SUCROSE STEARATE, CHOLESTEROL, PALMITIC ACID, CHOLESTERYL MACADAMIATE, SACCHARIDE ISOMERATE, HYDROLYZED LUPINE PROTEIN, SODIUM HYALURONATE

Powerproof Sunscreen 100

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

powerproof sunscreen 100powerproof sunscreen 100

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52554-1112-22022-01-28C16284748780-1d6a99b39-e9d1-a426-e053-dadaa90af4c2Powerproof Sunscreen 100

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52554-1112-1Powerproof Sunscreen 10050 mL in 1 TUBECREAM503
52554-1112-2Powerproof Sunscreen 1001 in 1 PACKAGECREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52554-1112POWERPROOF SUNSCREEN 100 (HOMOSALATE, OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM [CMS LAB INC.]3Legacy NDC, 2 package rows20171107_e9a80816-2f04-45be-96aa-9be2e5e9d2f9.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
52554-111252554-1112-1, 52554-1112-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
HomosalateV06SV4M95SACTIB
Octinoxate4Y5P7MUD51ACTIB
Zinc OxideSOI2LOH54ZACTIM
Titanium Dioxide15FIX9V2JPACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
HEXAMETHYLDISILOXANED7M4659BPUIACT
ALCOHOL3K9958V90MIACT
METHICONE (20 CST)6777U11MKTIACT
DIBUTYL ADIPATEF4K100DXP3IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
DIMETHICONE92RU3N3Y1OIACT
DIPROPYLENE GLYCOLE107L85C40IACT
POLYSILICONE-15F8DRP5BB29IACT
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEANQ870JD20IACT
PROPANEDIOL5965N8W85TIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PURSLANEM6S840WXG5IACT
CENTELLA ASIATICA7M867G6T1UIACT
HOUTTUYNIA CORDATA FLOWERING TOPRH041UUZ22IACT
BEMOTRIZINOLPWZ1720CBHIACT
CALCIUM ALUMINUM BOROSILICATE3JRB8A35M0IACT
INVERT SUGARED959S6ACYIACT
TURMERIC856YO1Z64FIACT
CHIA SEEDNU0OLX06F8IACT

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
d7a17996-5508-41a4-9067-1dfe1b564551e9a80816-2f04-45be-96aa-9be2e5e9d2f92017-11-06WarningsExact identifier
spl id: d7a17996-5508-41a4-9067-1dfe1b564551
spl set id: e9a80816-2f04-45be-96aa-9be2e5e9d2f9

Reported adverse events (FAERS/openFDA)#

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