SOLAR SHIELD FACE AND BODY SPF 40- zinc oxide cream 
BRIGHT SKINCARE, LLC

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Active Ingredients:

Zinc Oxide 20%

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 broken or damaged skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Warnings:

Keep out of reach of children

Directions:

Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value 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.

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Other Information:

  • SAMPLE NOT FOR RESALE
  • Reef friendly
  • Cruelty free
  • Non-comedogenic
  • Suiteable for all skin types

Package Label

SOLAR SHIELD FACE AND BODY SPF 40 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85944-205
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOHEXASILOXANE (UNII: XHK3U310BA)  
TRIETHANOLAMINE (UNII: 9O3K93S3TK)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:85944-205-151.5 g in 1 PACKET; Type 0: Not a Combination Product10/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/27/2023
Labeler - BRIGHT SKINCARE, LLC (030046454)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc.793406000manufacture(85944-205)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372analysis(85944-205)

Revised: 7/2025
 
BRIGHT SKINCARE, LLC