Daily Defense SPF 50: Package Insert and Label Information

DAILY DEFENSE SPF 50- octisalate, zinc oxide and octocrylene lotion
Physicians Care Alliance, LLC (d/b/a PCA Skin)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredients

Octisalate (4.9%)

Octocrylene (9.5%)

Zinc Oxide (9.1%)

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

Stop use and ask a doctor if skin rash occurs

When using this product keep out of eyes. Rinse with water to remove.

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

– Use a water resistant sunscreen if swimming or sweating

-Reapply at least every two hours

-Children under 6 months: ask a doctor

-Sun Protectin 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 skin protecting measures including:

  • limit time in the sun, especially from 10 a.m. — 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

Other informaiton

Protect this product from excessive heat and direct sun

Inactive ingredients

Avena Sativa (Oat) Bran Extract

Bisabolol

Butylene Glycol

Butyloctyl Salicylate

Caffeine

Caprylyl Methicone

Citrus Aurantium Dulcis (Orange) Peel Extract

Cyclopentasiloxane

Ectoin

Ethyl Ferulate

Ethylhexylglycerin

Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer

Octyldodecyl Neopentanoate

Oleth-3 Phosphate

PEG-7 Trimethylolpropane Coconut Ether

Phenoxyethanol

Polyisobutene

Propanediol

Silybum Marianum Seed Extract

Sodium Hyaluronate

Sodium Stearoyl Glutamate

Tocopheryl Acetate

Triethoxycaprylylsilane

Water

Questions or Comments?

877.722.7546

labels

0.25 oz
(click image for full-size original)
1.7 primary artwork
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DAILY DEFENSE SPF 50
face sunscreen lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68726-265
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 9.1 g in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
CAFFEINE
OLETH-3 PHOSPHATE
BUTYLOCTYL SALICYLATE
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
ETHYL FERULATE
CAPRYLYL TRISILOXANE
.ALPHA.-TOCOPHEROL ACETATE
CYCLOMETHICONE 5
OCTYLDODECYL NEOPENTANOATE
WATER
ORANGE PEEL
HYALURONATE SODIUM
PROPANEDIOL
ECTOINE
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)
TRIETHOXYCAPRYLYLSILANE
POLYISOBUTYLENE (1000 MW)
SODIUM STEAROYL GLUTAMATE
LEVOMENOL
BUTYLENE GLYCOL
MILK THISTLE
OAT BRAN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68726-265-11 50 mL in 1 TUBE None
2 NDC:68726-265-37 7.4 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 05/01/2020
Labeler — Physicians Care Alliance, LLC (d/b/a PCA Skin) (969945133)

Revised: 12/2020 Physicians Care Alliance, LLC (d/b/a PCA Skin)

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