SANTO REMEDIOS PIEL ETERNA RADIANCE SUNSCREEN PRIMER SPF-42- titanium dioxide, zinc oxide lotion 
SANTO REMEDIO LLC

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SANTO REMEDIO'S Piel Eterna Radiance Sunscreen Primer SPF-42

Drug Facts

Active ingredients

Titanium Dioxide 6% Zinc Oxide 8%

Purpose

Sunscreen

Uses:

Warnings:

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 doctor if

  • Rash occurs.

Keep out of reach of children.

If swallowed, get medical help, or contact a Poison Control Center right away.

If pregnant or breastfeeding,

Ask a health professional before use.

Directions:

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:

Other information.

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.

Questions?

(855) REMEDIO

Package Labeling:

Label

SANTO REMEDIOS PIEL ETERNA RADIANCE SUNSCREEN PRIMER SPF-42 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81352-321
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
COCONUT OIL (UNII: Q9L0O73W7L)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 4 (UNII: CZ227117JE)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
RASPBERRY (UNII: 4N14V5R27W)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81352-321-0050 mL in 1 TUBE; Type 0: Not a Combination Product03/21/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/21/2022
Labeler - SANTO REMEDIO LLC (117456185)

Revised: 11/2023
Document Id: 09769ae3-d18d-e2dd-e063-6294a90a1f64
Set id: 82d210bc-b7ca-4d74-be58-85f175a75058
Version: 2
Effective Time: 20231106
 
SANTO REMEDIO LLC