RECAPTURE 360 DAY PLUS IR DEFENSE- avobenzone, octocrylene, and octinoxate cream

Recapture 360 Day plus IR Defense by

Drug Labeling and Warnings

Recapture 360 Day plus IR Defense by is a Otc medication manufactured, distributed, or labeled by Atlantic Coast Media Group, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.0%	Sunscreen
Octinoxate 7.5%	Sunscreen
Octocrylene 4.2%	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 rash occurs.

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

Keep out of reach of children. If 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 2 hours
• Children under 6 months: Ask a doctor
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a Broad Spectrum SPF 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-sleeve shirts, pants, hats and sunglasses

Other information

• Protect the product in this container from excessive heat and direct sunlight
• You may report a serious adverse reaction from using this product to Report Reaction, LLC.

PO Box 22, Plainsboro, NJ 08536-0222

Inactive ingredients

Water, Isododecane, Cyclopentasiloxane, Cetyl Alcohol, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Sodium Potassium Aluminum Silicate, Ethylhexyl Methoxycrylene, Xylitylglucoside, Diethylhexyl Syringylidenemalonate, Phormidium Persicinum Extract, Laminaria Digitata Extract, Simmondsia Chinensis (Jojoba) Seed Extract, Polygonum Aviculare Extract, Methylglucoside Phosphate, Copper Lysinate/Prolinate, Aminopropyl Ascorbyl Phosphate, Micrococcus Lysate, Bakuchiol, Lecithin, Ergothioneine, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Cichorium Intybus (Chicory) Root Extract, Pyrus Malus (Apple) Fruit Extract, Prunus Armeniaca (Apricot) Fruit Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Coffea Arabica (Coffee) Leaf/Seed Extract, Cinnamomum Cassia Bark Extract, Camellia Sinensis Leaf Extract, Arabidopsis Thaliana Extract, Glycine Soja (Soybean) Oil, Eugenia Caryophyllus (Clove) Flower Extract, Cucumis Melo Cantalupensis Fruit Extract, Orchis Mascula Flower Extract, Cananga Odorata Flower Extract, Rose Extract, Stearyl Dimethicone, Sea Water, Octadecane, Cetearyl Alcohol, Silica, Anhydroxylitol, Coco-Glucoside, Carbomer, Ethylhexylglycerin, Aminomethyl Propanol, Xylitol, Sodium Dehydroacetate, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Caprylic/Capric Triglyceride, Calcium Hydroxymethionine, 3-Aminopropane Sulfonic Acid, Polysorbate 20, Disodium EDTA, Hydroxyethylcellulose, Pentylene Glycol, Phenoxyethanol, Chlorphenesin, Benzyl Alcohol, Mica, Tin Oxide, Titanium Dioxide

Questions or Comments?

Call Toll-Free 1-800-548-1736
24 Hours, Monday – Sunday

PRINCIPAL DISPLAY PANEL - Jar Label

CHRISTIE BRINKLEY™
AUTHENTIC SKINCARE

Recapture 360 + IR Defense

ANTI-AGING DAY TREATMENT
BROAD SPECTRUM SPF 30 SUNSCREEN

INGREDIENTS AND APPEARANCE

RECAPTURE 360 DAY PLUS IR DEFENSE 
avobenzone, octocrylene, and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70550-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	42 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
PHORMIDIUM PERSICINUM (UNII: ZA983U4810)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)
BAKUCHIOL (UNII: OT12HJU3AR)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SHEA BUTTER (UNII: K49155WL9Y)
CHICORY ROOT (UNII: 090CTY533N)
APPLE (UNII: B423VGH5S9)
APRICOT (UNII: 269CJD5GZ9)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
CHINESE CINNAMON (UNII: WS4CQ062KM)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
SOYBEAN OIL (UNII: 241ATL177A)
CLOVE (UNII: K48IKT5321)
CANTALOUPE (UNII: 8QF5D5H6UH)
ORCHIS MASCULA FLOWER (UNII: 6H1JQK35LA)
CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTADECANE (UNII: N102P6HAIU)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
COCO GLUCOSIDE (UNII: ICS790225B)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
DESMENINOL CALCIUM (UNII: 1VK0YS654L)
TRAMIPROSATE (UNII: 5K8EAX0G53)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MICA (UNII: V8A1AW0880)
STANNIC OXIDE (UNII: KM7N50LOS6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70550-001-69	1 in 1 CARTON	03/01/2015
1		30 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 70550-001-14	1 in 1 CARTON	03/01/2015
2		30 mL in 1 JAR; Type 0: Not a Combination Product
3	NDC: 70550-001-49	1 in 1 CARTON	03/01/2015
3		15 mL in 1 JAR; Type 0: Not a Combination Product
4	NDC: 70550-001-70	1 in 1 CARTON	03/01/2015
4		45 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2015

Labeler - Atlantic Coast Media Group, LLC. (800337946)