Drug Labeling and Warnings

Drug Details [pdf]

MACROANTIOXIDANT SUN PROTECTION- avobenzone, homosalate, octinoxate, octocrylene, oxybenzone cream 
Natura Bisse International SA

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.

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Active Ingredients                                                 Purpose

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

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

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

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

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

Uses

helps prevent sunburn

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

Natura Bissé Barcelona

C+C Oil-Free MacroAntioxidant Sun Protection

Broad Spectrum SPF 30

Net Wet 1 oz 30 ml

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

• 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 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).

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63730-397
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 LINOLENATE (UNII: SGB6X4G86K)
GELATIN (UNII: 2G86QN327L)
LEVOMENOL (UNII: 24WE03BX2T)
CITRUS NOBILIS (UNII: 8MFF77J91V)
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)
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: 63730-397-01	30 g in 1 PACKAGE; Type 0: Not a Combination Product	03/08/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/08/2017	06/27/2019

Labeler - Natura Bisse International SA (464431576)

Establishment
Name	Address	ID/FEI	Business Operations
Natura Bisse International SA		464431576	manufacture(63730-397)

Revised: 6/2019

Document Id: 8c52021f-dc01-bf49-e053-2a95a90a33c7

34390-5

Set id: 4a366379-9a29-729a-e054-00144ff88e88

Version: 4

Effective Time: 20190627