DYNAMIC RESURFACING SPF 30- avobenzone, octinoxate, and octocrylene cream

Dynamic Resurfacing by

Drug Labeling and Warnings

Dynamic Resurfacing 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 1.0% }
Octinoxate 1.0% }
Octocrylene 0.5% }

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, Coco-Caprylate, Glycerin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Isostearyl Alcohol, Butylene Glycol, Butylene Glycol Cocoate, Rubus Idaeus (Raspberry) Seed Oil, Phenoxyethanol, Tocopheryl Acetate, Carbomer, Chlorphenesin, Melissa Officinalis Leaf Extract, Propylene Glycol, Sodium Stearoyl Glutamate, Behenyl Alcohol, Ethylcellulose, Lecithin, Xanthan Gum, Butyrospermum Parkii (Shea) Butter, Tocopherol, Papain, Borago Officinalis Seed Oil, Fragrance, Disodium EDTA, Sodium Hydroxide, Sodium Dehydroacetate, Hydrogenated Castor Oil, Stearyl Alcohol, Euphrasia Officinalis Extract, Mimosa Tenuiflora Bark Extract, Protease, Biosaccharide Gum-1, Citric Acid, Codium Tomentosum Extract, Ecklonia Cava Extract, Gelidium Cartilagineum Extract, Hizikia Fusiforme Extract, Myrtus Communis Leaf Extract, Potassium Sorbate, Sodium Benzoate, Subtilisin, Poria Cocos Extract, Citrus Aurantium Amara (Bitter Orange) Leaf/Twig Oil.

Questions?

US T: 1-855-235-3647

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

ANTI-AGEING

ELEMIS

DYNAMIC RESURFACING
DAY CREAM SPF 30

Skin smoothing day cream
Broad Spectrum SPF 30 | Sunscreen

• 💧 For uneven, dull skin
• 💧 Tri – Enzymes, Poria Cocos, Raspberry Seed oil
• 💧 Renews, smoothes, hydrates

50 ml e 1.6 US fl.oz.

INGREDIENTS AND APPEARANCE

DYNAMIC RESURFACING  SPF 30
avobenzone, octinoxate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65912-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	10 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	10 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE (UNII: 4828G836N6)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
RASPBERRY SEED OIL (UNII: 9S8867952A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
DOCOSANOL (UNII: 9G1OE216XY)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
XANTHAN GUM (UNII: TTV12P4NEE)
SHEA BUTTER (UNII: K49155WL9Y)
TOCOPHEROL (UNII: R0ZB2556P8)
PAPAIN (UNII: A236A06Y32)
BORAGE SEED OIL (UNII: F8XAG1755S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
EUPHRASIA STRICTA (UNII: C9642I91WL)
MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CODIUM TOMENTOSUM (UNII: B8B45BRU87)
ECKLONIA CAVA (UNII: UXX2N5V39P)
GELIDIUM CARTILAGINEUM (UNII: 37LBZ0E1UE)
SARGASSUM FUSIFORME (UNII: X436TJ4A11)
MYRTUS COMMUNIS LEAF (UNII: U20N87188F)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUBTILISIN (UNII: 0ZP13EBC5Y)
FU LING (UNII: XH37TWY5O4)
CITRUS AURANTIUM LEAFY TWIG OIL (UNII: 5K6H1IMT3D)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65912-002-50	1 in 1 CARTON	03/05/2018
1		50 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 65912-002-51	50 g in 1 JAR; Type 0: Not a Combination Product	03/05/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/05/2018

Labeler - ELEMIS Limited (399838895)