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

Daily Defence Shield by

Drug Labeling and Warnings

Daily Defence Shield by is a Otc medication manufactured, distributed, or labeled by ELEMIS Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	14 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	14 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COCO-CAPRYLATE (UNII: 4828G836N6)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PANTHENOL (UNII: WV9CM0O67Z)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
COCONUT OIL (UNII: Q9L0O73W7L)
JOJOBA OIL (UNII: 724GKU717M)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ARGANIA SPINOSA LEAF (UNII: 51XV5WTF7E)
CARNOSINE (UNII: 8HO6PVN24W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
PENTYLENE GLYCOL (UNII: 50C1307PZG)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65912-003-41	1 in 1 CARTON	06/04/2018
1		40 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 65912-003-43	40 g in 1 TUBE; Type 0: Not a Combination Product	06/04/2018

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)