solvaderm universal tinted moisturizer sunscreen spf 30

solvaderm universal tinted moisturizer sunscreen spf 30
SPL v1
SPL
SPL Set ID 86dbd8c3-e95a-49a8-afe6-ff9d985e28ba
Route
topical
Published
Effective Date 2025-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
ethylhexyl methoxycinnamate (75 mg) zinc cation (185 mg)
Inactive Ingredients
butyloctyl salicylate camellia oleifera leaf medium-chain triglycerides cyclopentasiloxane dimethicone edetate disodium ethylhexylglycerin glycerin 1,2-hexanediol ferric oxide red ferric oxide yellow ferrosoferric oxide niacinamide octyldodecyl neopentanoate oleth-10 phenoxyethanol polyacrylate-13 polysorbate 20 polysorbate 60 sodium hyaluronate sorbitan isostearate .alpha.-tocopherol acetate triethoxycaprylylsilane water xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-05-19
Purpose

Sunscreen

Description

Octinoxate 7.50% Zinc Oxide 18.50%

Medication Information

Warnings

For external use only

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.
Purpose

Sunscreen

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.

Description

Octinoxate 7.50% Zinc Oxide 18.50%

Do Not Use
  • on damaged or broken skin
Drug Facts

Active Ingredient

Octinoxate 7.50%

Zinc Oxide 18.50%

Package Labeling:

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.

Structured Label Content

Warnings

For external use only

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.
Purpose

Sunscreen

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 (Other information)
  • protect the product in this container from excessive heat and direct sun
Inactive Ingredients (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.

Do Not Use (Do not use)
  • on damaged or broken skin
Drug Facts

Active Ingredient (Active ingredient)

Octinoxate 7.50%

Zinc Oxide 18.50%

Package Labeling:

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:11.365675 · Updated: 2026-03-14T23:08:48.977444