78 X 36 SPF 30 ACTIVE- zinc oxide cream

78 x 36 SPF 30 Active by

Drug Labeling and Warnings

78 x 36 SPF 30 Active by is a Otc medication manufactured, distributed, or labeled by Dermazone Solutions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredients

Zinc Oxide 20%

Purpose

Sunscreen

USES

Helps prevent sunburn

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

WARNINGS

• For external use only.

• Do not use on damaged or broken skin.

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

• Stop use and ask a doctor if rash occurs.

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

DIRECTIONS

Apply liberally 15 minutes before sun exposure. Reapply:

• * Immediately after towel drying
• * At least every 2 hours

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 of 15 or higher and other sun protection measures including:

• * Limit time in the sun, especially from 10 a.m. - 2 p.m.
• * Wear long-sleeve shirts, pants, hats, and sunglasses
• * Children under 6 months: Ask a Doctor

OTHER INFORMATION

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

INACTIVE INGREDIENTS

Acetyl Ethylhexyl Polyhydroxystearate, Alcohol, Artemia Extract, C9-12 Alkane, Caprylic/Capric Triglycerides, Coco-Caprylate/Caprate, Ethylhexylglycerin,Fragrance, Glycerin, Isoamyl Laurate, Lecithin, Phenoxyethanol, Polyurethane-100, Potassium Cetyl Phosphate, Purified Water, Silica, Sodium Chloride, Sorbitan Olivate, Triheptanoin, Xanthan Gum.

PRINCIPAL DISPLAY PANEL - 96 g Tube Carton

BROAD SPECTRUM

78 x 36

SPF 30
ACTIVE

PROTECT YOUR SKIN
PROTECT YOUR GAME

SPORTS
SWEAT PROTECTION
80 MINUTES

3.4 OZ
96g

INGREDIENTS AND APPEARANCE

78 X 36 SPF 30 ACTIVE 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58466-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.2 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
C9-12 ALKANE (UNII: 7J5R5W72QM)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITAN OLIVATE (UNII: MDL271E3GR)
TRIHEPTANOIN (UNII: 2P6O7CFW5K)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58466-109-03	1 in 1 CARTON	10/01/2023
1		96 g 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 not final	part352	10/01/2023

Labeler - Dermazone Solutions, Inc. (136116865)

Establishment
Name	Address	ID/FEI	Business Operations
Dermazone Solutions, Inc.		136116865	MANUFACTURE(58466-109)