SAFEGUARD SPF 40- zinc oxide cream

Safeguard SPF 40 by

Drug Labeling and Warnings

Safeguard SPF 40 by is a Otc medication manufactured, distributed, or labeled by Skinsalvation Skincare, Inc., Custom Analytics LLC, Fragrance Manufacturing Inc. (FMI). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

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 damaged or broken skin

• 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 product is swallowed, get medical help or contact a Poison Control Center right away

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply: - after 40 minutes of swimming or sweating - immediately after towel drying - at least every two hours
• 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 of 15 or higher and other skin protection measures including:
  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
• Children under 6 months: ask a doctor

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

• Protect this product from excessive heat and direct sun
• May stain some fabrics
• For easier application, dispense onto and rub between fingertips to warm before applying.

Questions or Comments?

made for with & within by skinsalvation skincare inc.

san francisco, ca 94109 | withandwithin.co

Principal Display Panel – 100 g Tube Label

with &
within

safeguard
SPF 40

clear skin for everyone

FACE
& BODY

broad spectrum spf 40

water resistant (40 minutes)

Net wt. 3.5 oz / 100 g

INGREDIENTS AND APPEARANCE

SAFEGUARD SPF 40 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83578-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE 100 (UNII: RO266O364U)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83578-205-35	100 g in 1 TUBE; Type 0: Not a Combination Product	06/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/30/2023

Labeler - Skinsalvation Skincare, Inc. (013319151)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	ANALYSIS(83578-205)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc. (FMI)		793406000	MANUFACTURE(83578-205) , PACK(83578-205)