BROAD SPECTRUM SPF 50 SUNSCREEN- zinc oxide lotion

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

WARNINGS

Warnings
For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask a dector if rash occurs

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BROAD SPECTRUM SPF 50 SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87693-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	235 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
EUPHORBIA CERIFERA (CANDELILLA) WAX (UNII: WL0328HX19)
C9-12 ALKANE (UNII: 7J5R5W72QM)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
POLYURETHANE-100 (UNII: U8WGJ642Z8)
OCTYLDODECANOL (UNII: 461N1O614Y)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
TRIHEPTANOIN (UNII: 2P6O7CFW5K)
NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)
ETHYL FERULATE (UNII: 5B8915UELW)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
HYDROGENATED CASTOR OIL/SEBACIC ACID COPOLYMER (UNII: H7DBQ4WF5M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87693-001-02	1 in 1 BOX	05/26/2026
1	NDC: 87693-001-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/26/2026

Labeler - SKIN DAMAGE INC. (138478676)