Santo Remedio's Piel Eterna Radiance Sunscreen Primer Spf-42

Santo Remedio's Piel Eterna Radiance Sunscreen Primer Spf-42
SPL v2
SPL
SPL Set ID 82d210bc-b7ca-4d74-be58-85f175a75058
Route
TOPICAL
Published
Effective Date 2022-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (60 mg) Zinc Cation (80 mg)
Inactive Ingredients
Green Tea Leaf Medium-chain Triglycerides Coconut Oil Cyclomethicone 5 Cyclomethicone 4 Dimethicone Helianthus Annuus Flowering Top Ferric Oxide Red Raspberry Silicon Dioxide Tetrahexyldecyl Ascorbate .alpha.-tocopherol Acetate Tridecyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-21

Description

Titanium Dioxide 6% Zinc Oxide 8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 6% Zinc Oxide 8%

Uses:
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Retains SPF after 80 minutes of swimming or sweating.
  • If used as as directed with other sun protection measures (see directions), decreases the risk of cancer and early skin aging caused by the sun.
Warnings:
  • For external use only
Do Not Use
  • On damaged or broken skin.
Questions?

(855) REMEDIO

Directions:
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures.
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Package Labeling:

Active Ingredients

Titanium Dioxide 6% Zinc Oxide 8%

Other Information.
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients:

Bis-Vinyl Dimethicone/ Dimethicone, Copolymer, Camellia Sinensis (Green Tea) Extract, Caprylic/ Capric Triglyceride, Cetyl, PEG/PPG-10/1 Dimethicone, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Dimethiconol, Helianthus Annus (Sunflower) Oil, Iron Oxides (Black, Red, White, Yellow), Rubus Idaeus (Rasperry) Extract, Silica, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate.

When Using This Product
  • Keep out of eyes. Rinse with water to remove.
Stop Use and Ask Doctor If
  • Rash occurs.
If Pregnant Or Breastfeeding,

Ask a health professional before use.

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.
  • Higher SPF gives more sunburn protection.
  • Retains SPF after 80 minutes of swimming or sweating.
  • If used as as directed with other sun protection measures (see directions), decreases the risk of cancer and early skin aging caused by the sun.
Purpose

Sunscreen

Warnings:
  • For external use only
Do Not Use (Do not use)
  • On damaged or broken skin.
Questions?

(855) REMEDIO

Directions:
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures.
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Package Labeling:

Active Ingredients (Active ingredients)

Titanium Dioxide 6% Zinc Oxide 8%

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

Bis-Vinyl Dimethicone/ Dimethicone, Copolymer, Camellia Sinensis (Green Tea) Extract, Caprylic/ Capric Triglyceride, Cetyl, PEG/PPG-10/1 Dimethicone, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Dimethiconol, Helianthus Annus (Sunflower) Oil, Iron Oxides (Black, Red, White, Yellow), Rubus Idaeus (Rasperry) Extract, Silica, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate.

When Using This Product (When using this product)
  • Keep out of eyes. Rinse with water to remove.
Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • Rash occurs.
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

Ask a health professional before use.

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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