SOLVADERM DERMAXSOL DERMAL DEFENSE MOISTURIZER SPF-30- octocrylene, zinc oxide cream

SOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-30 by

Drug Labeling and Warnings

SOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-30 by is a Otc medication manufactured, distributed, or labeled by SOLVADERM LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENTS:

Octocrylene 10.0% 
Zinc Oxide 7.0%

PURPOSE

Sunscreen

USES:

Helps prevent sunburn.

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 to all skin exposed to the sun.

*Apply liberally and evenly 15 minutes before sun exposure.

*Reapply at least every 2 hours.

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

*If pregnant or breast-feeding, ask a health care professional before use.

*For children under 6 months of age: Ask a doctor.

INACTIVE INGREDIENTS:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aluminum Starch Octenyl succinate, Aqua (Deionized Water), Beeswax, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Chamomilla Matricaria Extract, Cetearyl Alcohol, Cyclopentasiloxane, Diisopropyl Adipate, Dimethicone, Dimethiconol, Ethylhexylglycerin, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Hyaluronic Acid, C13-14 Isoparaffin, Laureth-7, Parfum (Fragrance)., PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Sorbitan Stearate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E).

OTHER INFORMATION:

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

Package Labeling:

INGREDIENTS AND APPEARANCE

SOLVADERM DERMAXSOL DERMAL DEFENSE MOISTURIZER SPF-30 
octocrylene, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84197-467
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	70 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
WATER (UNII: 059QF0KO0R)
YELLOW WAX (UNII: 2ZA36H0S2V)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL LAURATE (UNII: Y98611C087)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYALURONIC ACID (UNII: S270N0TRQY)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84197-467-00	1 in 1 BOX	03/04/2024
1		50 g in 1 JAR; 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	03/04/2024

Labeler - SOLVADERM LLC (093262409)