MACROANTIOXIDANT SUN PROTECTION- avobenzone, homosalate, octinoxate, octocrylene, oxybenzone cream

Macroantioxidant Sun Protection by

Drug Labeling and Warnings

Macroantioxidant Sun Protection by is a Otc medication manufactured, distributed, or labeled by Natura Bisse International SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                                 Purpose

Avobenzone 3% .................................................... Sunscreen

Homosalate 10% ................................................... Sunscreen

Octinoxate 7.5% .................................................... Sunscreen

Octocrylene 10% ................................................... Sunscreen

Oxybenzone 3% .................................................... Sunscreen

PURPOSE

Uses

helps prevent sunburn

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Natura Bissé Barcelona

C+C Oil-Free MacroAntioxidant Sun Protection

Broad Spectrum SPF 30

Net Wet 1 oz 30 ml

DOSAGE & ADMINISTRATION

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 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. - 2p.m.
• wear long-sleeved shirts, pants, hats, and sun-glasses.

WARNINGS

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.

INACTIVE INGREDIENT

Inactive Ingredients

water, alcohol denat., propanediol, glycerin, propylheptyl caprylate, glyceryl stearate, oryza sativa (rice) starch, PEG-100 stearate, benzotriazolyl dodecyl p-cresol, citrus sinensis (orange) peel extract, tocopheryl acetate, glyceryl linoleate, hydrolyzed collagen, bisabolol, citrus nobilis (mandarin orange) oil, citrus aurantium dulcis (orange) oil, glyceryl linolenate, 7-dehydrocholesterol, polyacrylate crosspolymer-11, disodium EDTA, glyceryl polyacrylate, ethylhexylglycerin, tricalcium phosphate, citric acid, phenoxyethanol, fragrance, limonene, linalool, amyl cinnamal, geraniol, yellow 5 (CI 19140), red 4 (CI 14700).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MACROANTIOXIDANT SUN PROTECTION 
avobenzone, homosalate, octinoxate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63730-340
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
PEG-100 STEARATE (UNII: YD01N1999R)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
CITRUS SINENSIS FRUIT OIL (UNII: WV48LBL15Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL LINOLEATE (UNII: 4763AXI84L)
GELATIN (UNII: 2G86QN327L)
LEVOMENOL (UNII: 24WE03BX2T)
CITRUS NOBILIS (UNII: 8MFF77J91V)
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)
GLYCERYL LINOLENATE (UNII: SGB6X4G86K)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+)- (UNII: F4VNO44C09)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
GERANIOL (UNII: L837108USY)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63730-340-01	30 g in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/02/2015

Labeler - Natura Bisse International SA (464431576)

Establishment
Name	Address	ID/FEI	Business Operations
Natura Bisse International SA		464431576	manufacture(63730-340)