Daily Defence Shield SPF 30: Package Insert and Label Information

DAILY DEFENCE SHIELD SPF 30- avobenzone, octinoxate and octocrylene cream
ELEMIS Limited

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.

Drug Facts

Active ingredients

Avobenzone 1.4% }
Octinoxate 1.4% }
Octocrylene 0.7%}

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection

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

Directions

  • apply liberally and evenly 15 minutes before sun exposure and as needed
  • children under 6 months of age: Ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin ageing. 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
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating

Other information

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

Water, Glycerin, Coco-Caprylate, Isostearyl Alcohol, Butylene Glycol Cocoate, Cetyl Alcohol, Phenoxyethanol, Panthenol, Butylene Glycol, Cocos Nucifera (Coconut) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Carbomer, Sodium Stearoyl Glutamate, Chondrus Crispus Powder, Lecithin, 1,2-Hexanediol, Ethylcellulose, Tocopherol, Ethylhexylglycerin, Argania Spinosa Leaf Extract, Carnosine, Tocopheryl Acetate, Disodium EDTA, Sodium Hydroxide, Biosaccharide Gum-4, Melanin, Pentylene Glycol.

Questions?

US T: 1-855-235-3647

PRINCIPAL DISPLAY PANEL — 40 ml Tube Carton

ADVANCED SKINCARE

ELEMIS

DAILY DEFENCE
SHIELD SPF 30

Broad Spectrum SPF 30
Sunscreen

  • Sun protection for all skin types
  • Enviro-Age Complex, Coconut, Jojoba
  • Defends, protects, hydrates

40 ml e 1.3 US fl.oz.

Outer Carton
(click image for full-size original)
DAILY DEFENCE SHIELD SPF 30
avobenzone, octinoxate, and octocrylene cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65912-003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 14 mg in 1 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 14 mg in 1 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 7 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
COCO-CAPRYLATE
ISOSTEARYL ALCOHOL
CETYL ALCOHOL
PHENOXYETHANOL
PANTHENOL
BUTYLENE GLYCOL
JOJOBA OIL
SODIUM STEAROYL GLUTAMATE
CHONDRUS CRISPUS
LECITHIN, SOYBEAN
1,2-HEXANEDIOL
ETHYLCELLULOSE, UNSPECIFIED
TOCOPHEROL
ETHYLHEXYLGLYCERIN
ARGANIA SPINOSA LEAF
CARNOSINE
.ALPHA.-TOCOPHEROL ACETATE
EDETATE DISODIUM ANHYDROUS
SODIUM HYDROXIDE
BIOSACCHARIDE GUM-4
MELANIN SYNTHETIC (TYROSINE, PEROXIDE)
PENTYLENE GLYCOL
MEDIUM-CHAIN TRIGLYCERIDES
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65912-003-41 1 TUBE in 1 CARTON contains a TUBE
1 40 g in 1 TUBE This package is contained within the CARTON (65912-003-41)
2 NDC:65912-003-43 40 g in 1 TUBE None
3 NDC:65912-003-52 40 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 06/04/2018
Labeler — ELEMIS Limited (399838895)

Revised: 12/2021 ELEMIS Limited

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