FDA.reportPublic FDA data

Broad Spectrum SPF 50 Sunscreen - SKIN DAMAGE INC.

Manufacturer
SKIN DAMAGE INC.
Effective date
2026-05-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:58:51

Label at a glance#

ProductBroad Spectrum SPF 50 Sunscreen
Active ingredientZINC OXIDE
Label structure12 sections

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Zinc Oxide - 23,5% ........ Sunscreen

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Helps prevent sunburn

WARNINGS SECTION

Warnings
For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a dector 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

DOSAGE & ADMINISTRATION SECTION

Directions
Apply liberally 15 minutes before sun
exposure Reapply after 80 minutes
of swimming or sweating immediately
after towel drying at least every 2 hours
Chiidren 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:
Imit time in the sun, especially from
10 a.m .- 2 p.m.
wear long-sleeved shirts, pants, hats
and sunglasses

INACTIVE INGREDIENT SECTION

Inactive ingredients
Neopentyl Glycol Diethylhexancate, Cera
Alba (Beeswax), Euphorbia Cerifera
(Candellla) Wax, Caprylic/Capric Triglyceride,
Hydrogenated Castor Oil/Sebacic Acid
Copolymer, Triheptanoin, Polyhydroxystearic
Acid, VP/Eicosene Copolymer, Argania
Spinosa Kermel Oil, Helianthus Annuus
(Sunflower) Seed Oil, C13-16 Isoalkane
Neopentyl Glycol Diisostearate, Butyrospermum
Parkii (Shea) Butter, Castor Isostearate
Succinate, Octyldodecanol, Octyldodecyl
Dilinoleyl
Alcohol/Succinic
Acid Copolymer, Ethyl Ferulate, Slica
Dimethyl Silylate, Coco-Caprylate/Caprate,
Triethoxycaprylsilane, C9-12 Akane
Polyurethane-100, Iron Oxides

STORAGE AND HANDLING SECTION

Protect the product in this container from
excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelingLabeling

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
124351b2-6dbf-42d0-9ea7-f0e299215f9aProduct name120210115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87693-001-01Broad Spectrum SPF 50 Sunscreen50 mL in 1 TUBELOTION501
87693-001-02Broad Spectrum SPF 50 Sunscreen1 in 1 BOXLOTION11

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87693-00187693-001-01, 87693-001-02

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
EUPHORBIA CERIFERA (CANDELILLA) WAXWL0328HX19IACT
C9-12 ALKANE7J5R5W72QMIACT
ARGANIA SPINOSA KERNEL OIL4V59G5UW9XIACT
POLYURETHANE-100U8WGJ642Z8IACT
OCTYLDODECANOL461N1O614YIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
TRIHEPTANOIN2P6O7CFW5KIACT
ZINC OXIDESOI2LOH54ZACTIB
NEOPENTYL GLYCOL DIISOSTEARATE4M6OQ34JWWIACT
ETHYL FERULATE5B8915UELWIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
HYDROGENATED CASTOR OIL/SEBACIC ACID COPOLYMERH7DBQ4WF5MIACT

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
Broad Spectrum SPF 50 SunscreenZINC OXIDESKIN DAMAGE INC.52ba2f12-839f-cea1-e063-6394a90a5ae62026-05-26WarningsExact identifier
ndc (package): 87693-001-01
ndc (package): 87693-001-02
ndc (product): 87693-001
ndc11 (package): 87693000102
ndc11 (package): 87693000101
spl id: 52ba2f12-83a0-cea1-e063-6394a90a5ae6
spl set id: 52ba2f12-839f-cea1-e063-6394a90a5ae6

Reported adverse events (FAERS/openFDA)#

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