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

Description

Octinoxate 7.50% Zinc Oxide 18.50%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.50% Zinc Oxide 18.50%

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

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.
Do Not Use
  • on damaged or broken skin
Drug Facts

Active Ingredient

Octinoxate 7.50%

Zinc Oxide 18.50%

Other Information
  • protect the product in this container from excessive heat and direct sun
Package Labeling:

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.

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

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

Warnings

For external use only

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

Active Ingredient (Active ingredient)

Octinoxate 7.50%

Zinc Oxide 18.50%

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
Package Labeling:

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.

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

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