FDA.reportPublic FDA data

SkinProtect SPF 50 SHEER ROLLER SUNSCREEN

Manufacturer
Mitchell Group USA, LLC
Effective date
2017-08-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:14:21

Label at a glance#

ProductSkinProtect SPF 50 SHEER ROLLER SUNSCREEN
Active ingredientHOMOSALATE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure7 sections

Indications and uses

Screens out sun’s burning rays to help prevent sunburn.

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

SkinProtect Sheer SPF

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10.00%
Octinoxate 7.50%
Octocrylene 7.50%
Octisalate 5.00%
Avobenzone 3.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

Screens out sun’s burning rays to help prevent sunburn.

Warnings:

WARNINGS SECTION

For external use only.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Sun Alert: UV exposure from the sun increases the risk of skin cancer, premature skin aging. Decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen.

Avoid contact with eyes.
Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if skin rash develops.

Other information:

SPL UNCLASSIFIED SECTION

store in cool dry place.

Ingredients:

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), C12-15 Alkyl Benzoate, Carbomer, Cetyl Alcohol, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hyaluronic Acid, Parfum (Fragrance), PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Potassium Hydroxide, Propylene Glycol, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E),

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71636-84171636-841-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CETYL ALCOHOL936JST6JCNIACT
COCONUT OILQ9L0O73W7LIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
HYALURONIC ACIDS270N0TRQYIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARYL ALCOHOL2KR89I4H1YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB

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
074ba069-b691-bad7-e063-6394a90ac4be55ddafc3-41b8-3566-e054-00144ff88e882023-10-09WarningsExact identifier
spl set id: 55ddafc3-41b8-3566-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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