SOLVADERM UNIVERSAL TINTED MOISTURIZER SUNSCREEN SPF 30- octinoxate, zinc oxide lotion

Solvaderm Universal Tinted Moisturizer Sunscreen SPF 30 by

Drug Labeling and Warnings

Solvaderm Universal Tinted Moisturizer Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by SOLVADERM LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Octinoxate 7.50%
Zinc Oxide 18.50%

Purpose

Sunscreen

Uses

• Helps prevent sunburn 
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months of age: ask a doctor.
• Reapply at least every 2 hours 
• Use a water-resistant sunscreen if swimming or sweating
• Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with 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-sleeved shirts, pants, hats, and sunglasses.

Other information

• protect the product in this container from excessive heat and direct sun

Inactive ingredients

Butyloctyl Salicylate, Camellia Oleifera Leaf Extract, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, 1,2-Hexanediol, Hydrogenated Polyisobutene, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides (CI 77491, CI 77492, CI 77499), Niacinamide, Octyldodecyl Neopentanoate, Oleth-10, Phenoxyethanol, Polyacrylate-13, Polyglyceryl-3 Polyricinoleate, Polyisobutene, Polysorbate 20, Polysorbate 60, Sodium Hyaluronate, Sorbitan Isostearate, Tocopheryl Acetate, Triethoxycaprylylsilane, Water (Aqua), Xanthan Gum.

Package Labeling:

INGREDIENTS AND APPEARANCE

SOLVADERM UNIVERSAL TINTED MOISTURIZER SUNSCREEN SPF 30 
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84197-967
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	185 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NIACINAMIDE (UNII: 25X51I8RD4)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
OLETH-10 (UNII: JD797EF70J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLATE-13 (UNII: FS2D4T67EA)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84197-967-00	59 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/19/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/19/2025

Labeler - SOLVADERM LLC (093262409)

Registrant - Pure Source, LLC (080354456)